Category: FDA
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Vinay Prasad, key Makary ally and a focus of controversy at the FDA, is leaving the agency
Vinay Prasad, key Makary ally and a focus of controversy at the FDA, is leaving the agency WASHINGTON — Vinay Prasad, a top official at the Food and Drug Administration who has been at the center of recurring public controversies, is exiting the agency for a second time. Prasad will leave the FDA at the…
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STAT+: The FDA, urged to avoid controversy, creates a new headache with attack against UniQure
STAT+: The FDA, urged to avoid controversy, creates a new headache with attack against UniQure There was a telling exchange during a Thursday media call set up by the Food and Drug Administration to enable a “senior FDA official” — he could only be quoted anonymously — to attack UniQure and its experimental treatment for…
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STAT+: Prime Medicine to seek approval for gene-editing treatment after two-patient trial
STAT+: Prime Medicine to seek approval for gene-editing treatment after two-patient trial Prime Medicine said Tuesday it will ask the Food and Drug Administration to approve a gene-editing treatment that has been given to only two patients. The application will test an agency that has promised to speed new gene-editing treatments to patients but has…
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STAT+: A rare disease drug was approvable, then it wasn’t. Inside a surprise rejection by the FDA
STAT+: A rare disease drug was approvable, then it wasn’t. Inside a surprise rejection by the FDA An experimental therapy for a rare blood cancer was on the path toward approval by the Food and Drug Administration last year — with internal reviewers recommending it be cleared — before the agency rejected the drug last…
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STAT+: FDA unveils rules for bespoke gene therapies, predicting flood of rare disease applications
STAT+: FDA unveils rules for bespoke gene therapies, predicting flood of rare disease applications The Trump administration on Monday released detailed guidance for approving the first bespoke medicines crafted to treat patients’ individual mutations. Food and Drug Administration Commissioner Marty Makary and biologics chief Vinay Prasad had already previewed the new approach, known as the plausible mechanism…
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Hims’ Super Bowl fallout, and the FDA reverses course
Hims’ Super Bowl fallout, and the FDA reverses course Was Hims’ Super Bowl ad the final straw for regulators? Is the bar being lowered for psychedelic medicines? And what’s happening behind-the-scenes with Moderna and the Food and Drug Administration? We discuss all that on this week’s episode of “The Readout LOUD.” STAT’s Katie Palmer joins…
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STAT+: In first speech to her FDA staff, Høeg says she’ll scrutinize RSV shots and SSRIs in pregnancy
STAT+: In first speech to her FDA staff, Høeg says she’ll scrutinize RSV shots and SSRIs in pregnancy WASHINGTON — Tracy Beth Høeg, the top drug regulator at the Food and Drug Administration, indicated in her first address to staff that she’ll scrutinize antidepressants and the shots used to protect babies from RSV. Høeg told…
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STAT+: FDA taps AI executive to lead digital health center
STAT+: FDA taps AI executive to lead digital health center The Food and Drug Administration has tapped a former executive from a health artificial intelligence company to lead its digital health center. Rick Abramson, formerly a chief medical officer at a subsidiary of Harrison.ai, which develops AI products to interpret radiological images, is the new…
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STAT+: New FDA guidance for antibiotic use in food-producing animals prompts criticism over antibiotic resistance
STAT+: New FDA guidance for antibiotic use in food-producing animals prompts criticism over antibiotic resistance In a bid to mitigate antibiotic resistance, the Food and Drug Administration has released guidance for drugmakers to define how long medically important antibiotics should be used in food-producing animals. But critics argue the effort fails to consider the impact…
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STAT+: Kennedy says he’ll act on legal challenge to ultra-processed foods
STAT+: Kennedy says he’ll act on legal challenge to ultra-processed foods Health secretary Robert F. Kennedy Jr. fired the starting gun in a challenge to the food industry on Sunday, announcing on CBS’ “60 Minutes” that he plans to act on a plan outlined by former Food and Drug Administration chief David Kessler to overhaul…
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STAT+: FDA rejects rare disease therapy from Disc Medicine, early recipient of commissioner’s voucher
STAT+: FDA rejects rare disease therapy from Disc Medicine, early recipient of commissioner’s voucher WASHINGTON — The Food and Drug Administration on Friday rejected bitopertin, a therapy developed by Disc Medicine to treat the rare blood disorder porphyria, which makes patients extremely sensitive to sunlight. It’s the first experimental drug to go through FDA Commissioner…
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STAT+: FDA’s rejection of Moderna threatens to stifle broader vaccine industry
STAT+: FDA’s rejection of Moderna threatens to stifle broader vaccine industry The Food and Drug Administration’s refusal to review Moderna’s flu vaccine this month has renewed fears that Trump administration policies could paralyze the vaccine industry, dissuading companies from developing new shots in the U.S. and leaving the country flat-footed in the event of future…
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STAT+: The messaging war over Medicaid cuts
STAT+: The messaging war over Medicaid cuts You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. Dr. Oz seems to have invited Jeffrey Epstein to a Valentine’s Day party in 2016, about eight…
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STAT+: FDA refuses to review Moderna’s influenza vaccine
STAT+: FDA refuses to review Moderna’s influenza vaccine The Food and Drug Administration refused to review Moderna’s application for a new influenza vaccine, the company said Tuesday, a surprise decision that could raise concerns about the agency’s posture toward drug companies and the Trump administration’s policies on vaccines. Moderna, revealing the rejection, took the unusual…
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STAT+: FDA warned a Hims & Hers compounder after finding bugs and failing to report a serious side effect
STAT+: FDA warned a Hims & Hers compounder after finding bugs and failing to report a serious side effect The Food and Drug Administration late last year issued a warning letter to MedisourceRx, a compounding pharmacy owned by Hims & Hers, six months after a facility was cited for troubling problems during an inspection. One…
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STAT+: HHS asks Justice Department to probe Hims & Hers over its cheaper compounded version of Wegovy
STAT+: HHS asks Justice Department to probe Hims & Hers over its cheaper compounded version of Wegovy The Department of Health and Human Services asked the Department of Justice to investigate Hims & Hers for potentially violating federal law over its plan to make a compounded version of a low-cost weight loss pill widely available…
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STAT+: FDA Commissioner Marty Makary tries to soothe staff concerns over voucher program
STAT+: FDA Commissioner Marty Makary tries to soothe staff concerns over voucher program WASHINGTON — At an employee town hall on Tuesday, Food and Drug Administration leaders tried to quell staff and external concerns about a controversial new program to fast-track certain drugs. “This pilot is an effort to make our review processes patient-centric,” said…
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STAT+: FDA officials push for long-term monitoring of autoimmune patients receiving CAR-T therapy
STAT+: FDA officials push for long-term monitoring of autoimmune patients receiving CAR-T therapy Food and Drug Administration officials are advising drug developers to study the long-term effects of using CAR-T to treat patients with autoimmune conditions, out of concern the therapies could cause cancer or fertility issues. The recommendations were outlined in an op-ed published…
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STAT+: On Day 4 of JPM, a chat with Regeneron’s George Yancopoulos, an IPO forecast, and all eyes on J&J
STAT+: On Day 4 of JPM, a chat with Regeneron’s George Yancopoulos, an IPO forecast, and all eyes on J&J This is the online version of The Readout, STAT’s flagship biotech newsletter. Sign up to get it in your inbox. We have made it! And so have you. This is Adam, Elaine, Matt, and Allison preparing to sign…
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STAT+: Watch: At JPM, former drug regulator Richard Pazdur rings the alarm about politics at FDA
STAT+: Watch: At JPM, former drug regulator Richard Pazdur rings the alarm about politics at FDA Richard Pazdur, a veteran regulator at the Food and Drug Administration until last month, joined STAT in San Francisco on Monday evening to make his first public remarks about the circumstances leading up to his abrupt departure. At an…
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STAT+: FDA puts off Stoke’s request for faster filing of severe epilepsy drug
STAT+: FDA puts off Stoke’s request for faster filing of severe epilepsy drug SAN FRANCISCO — Stoke Therapeutics and the Food and Drug Administration were unable to reach agreement on an expedited submission for the company’s severe epilepsy treatment, the company said Sunday. Following a meeting in December, the FDA did not shut the door…
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STAT+: FDA announces sweeping changes to oversight of wearables, AI-enabled devices
STAT+: FDA announces sweeping changes to oversight of wearables, AI-enabled devices LAS VEGAS — The Food and Drug Administration announced Tuesday that it will ease regulation of digital health products, following through on the Trump administration’s promises to deregulate artificial intelligence and promote its widespread use. FDA Commissioner Marty Makary indicated that one of the…
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STAT+: The 3 biggest issues to watch in vaccine policy in 2026
STAT+: The 3 biggest issues to watch in vaccine policy in 2026 WASHINGTON — Vaccine policy has become a key issue for the Trump administration, especially under the leadership of health secretary Robert F. Kennedy Jr., who himself once led an anti-vaccine group. In less than a year, Kennedy has bulldozed vaccine policy precedent and…
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STAT+: Trump moves to require lower drug prices in Medicare
STAT+: Trump moves to require lower drug prices in Medicare You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. The NIH director did the Pete & Bobby fitness challenge, but I didn’t see…
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STAT+: Cytokinetics heart drug wins FDA approval, the biotech’s first
STAT+: Cytokinetics heart drug wins FDA approval, the biotech’s first It took 27 years, but Cytokinetics secured its first U.S. drug approval. On Friday, the Food and Drug Administration cleared the new medicine, called Myqorzo, to treat patients with obstructive hypertrophic cardiomyopathy, an inherited heart disorder. Cytokinetics said it will begin selling Myqorzo in late…
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In major effort to end gender-affirming care, Trump administration takes aim at hospitals
In major effort to end gender-affirming care, Trump administration takes aim at hospitals The Trump administration is making its most forceful attempt yet at restricting gender-affirming care for transgender youth in the U.S. The Centers for Medicare and Medicaid Services proposed on Thursday two rules to withhold federal funds in connection with gender-affirming care for…
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Opinion: STAT readers respond to essays on miracles, vaccines, and more
Opinion: STAT readers respond to essays on miracles, vaccines, and more First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others. To encourage robust, good-faith discussion about issues raised in First Opinion essays, STAT publishes selected Letters to…
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FDA approves first new kind of drug to target gonorrhea in decades
FDA approves first new kind of drug to target gonorrhea in decades A new kind of oral antibiotic to treat gonorrhea has secured Food and Drug Administration approval, the second time in two days that a new drug for the common sexually transmitted infection has come through licensure. Neisseria gonorrhoeae, the bacterium that causes gonorrhea,…
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FDA approves first new gonorrhea drug in decades
FDA approves first new gonorrhea drug in decades The bacterium that causes gonorrhea has been steamrolling its way through all the antibiotics available to treat it, with a single drug, ceftriaxone, left struggling to quell infections. On Thursday, help arrived. Read the rest… Helen Branswell Go to statnews
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Botulism outbreak sickens more than 50 babies and expands to all ByHeart products
Botulism outbreak sickens more than 50 babies and expands to all ByHeart products Federal health officials on Wednesday expanded an outbreak of infant botulism tied to recalled ByHeart baby formula to include all illnesses reported since the company began production in March 2022. The U.S. Food and Drug Administration said investigators “cannot rule out the possibility that…
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Opinion: Why comparing the U.S. vaccine schedule to European countries’ is a red herring
Opinion: Why comparing the U.S. vaccine schedule to European countries’ is a red herring If any ambiguity remained about the ultimate goal of the current administration’s public health policy, last week shattered it. On Friday, following a disastrous two-day meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), President…
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STAT+: Vinay Prasad, FDA’s vaccine regulator, waves off criticism in closed-door remarks
STAT+: Vinay Prasad, FDA’s vaccine regulator, waves off criticism in closed-door remarks NEW YORK — Vinay Prasad, the Food and Drug Administration’s top vaccines regulator, blamed “misleading media narratives” for the escalating criticism of his leadership amid turmoil and plummeting morale at the agency. Prasad’s remarks, delivered Thursday at a New York investor conference closed…
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A new top drug regulator and the future of psychedelics
A new top drug regulator and the future of psychedelics On this week’s episode of “The Readout Loud”: a look at an emerging class of psychedelic drugs that may treat depression, anxiety, and other psychiatric conditions without the hallucinogenic “trip.” Plus, a dash through the week’s biotech news. The turmoil at the Food and Drug…
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A dozen former FDA commissioners decry Prasad memo on vaccine regulation
A dozen former FDA commissioners decry Prasad memo on vaccine regulation Changes to the ways in which the Food and Drug Administration plans to regulate vaccines represent a threat to effective and available vaccines and public health, 12 former commissioners wrote Wednesday in the New England Journal of Medicine. The changes, as described in a…
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STAT+: FDA removes longtime over-the-counter drugs regulator from her position
STAT+: FDA removes longtime over-the-counter drugs regulator from her position WASHINGTON — The Food and Drug Administration removed the longtime director of the office of over-the-counter drugs from her position on Wednesday, six agency sources told STAT. Theresa Michele, director of the Office of Nonprescription Drugs, has worked at the FDA since at least 2015.…
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STAT+: Top drug regulator Richard Pazdur set to leave the FDA
STAT+: Top drug regulator Richard Pazdur set to leave the FDA WASHINGTON — Top drug regulator Richard Pazdur has filed papers to retire from the Food and Drug Administration at the end of this month, adding to the turmoil atop the agency. Pazdur informed leaders at the FDA’s drug center of his intention to leave…
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STAT+: ACA tax credits cool, while BIOSECURE heats up
STAT+: ACA tax credits cool, while BIOSECURE heats up You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. MAHA Action has a holiday shop for all your MAHA gift giving needs. Or you can click over…
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STAT+: FDA offers staff ‘agentic AI’ to support premarket reviews, administrative tasks
STAT+: FDA offers staff ‘agentic AI’ to support premarket reviews, administrative tasks The Food and Drug Administration on Monday announced plans to offer its employees a broader set of artificial intelligence tools to use in premarket reviews and for other purposes amid persistent concerns that the technology can behave unpredictably. The agency touts in a…
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Experts say top FDA official’s claim that Covid vaccines caused kids’ deaths requires more evidence
Experts say top FDA official’s claim that Covid vaccines caused kids’ deaths requires more evidence The Food and Drug Administration’s top vaccine regulator asserted in an email to staff sent Friday that the Covid-19 vaccine caused at least 10 deaths in children and called for changes to the way the agency regulates vaccines. But experts…
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STAT+: FDA review staff was excluded from voting on whether to approve first priority voucher drug
STAT+: FDA review staff was excluded from voting on whether to approve first priority voucher drug WASHINGTON — The Food and Drug Administration has promised companies that earn a Commissioner’s National Priority Voucher a one- to two-month drug review, culminating in a one day “tumor board” style meeting where leaders decide whether to approve the drug. …
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STAT+: FDA’s stronger warning on Sarepta gene therapy raises new questions about heart risk
STAT+: FDA’s stronger warning on Sarepta gene therapy raises new questions about heart risk New warnings and restrictions placed on Sarepta Therapeutics’ gene therapy last week by the Food and Drug Administration have cast a spotlight on an important but overlooked heart-safety risk. “Acute, serious, and life-threatening” cases of heart inflammation called myocarditis and elevations…
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STAT+: FDA clears spinal cord stimulator for home use
STAT+: FDA clears spinal cord stimulator for home use The Food and Drug Administration has green-lit home use of a device that helps people with spinal cord injuries regain mobility and functioning. Onward Medical announced Monday that the company had received clearance to expand the use of its spinal cord stimulator outside of clinics. “People…
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Opinion: Celebrating a new, faster path to gene-editing medicines on demand
Opinion: Celebrating a new, faster path to gene-editing medicines on demand In May, news broke of a biomedical first: the on-demand design and clinical use of a personalized gene editor for a baby boy born with a rare, severe genetic condition. At the STAT Summit in October, the child’s treating physician from the Children’s Hospital…
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STAT+: GOP ACA proposal complicates negotiations
STAT+: GOP ACA proposal complicates negotiations You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. Packing “longevity” items for a flight to a MAHA event in Washington was such a pain that it…
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STAT+: FDA chiefs offer roadmap to expand custom gene-editing treatments like Baby KJ’s
STAT+: FDA chiefs offer roadmap to expand custom gene-editing treatments like Baby KJ’s Top Food and Drug Administration officials on Wednesday detailed a roadmap for approving the world’s first personalized gene-editing treatments. The perspective, published in the New England Journal of Medicine, comes six months after researchers announced they had crafted a custom gene-editing treatment…
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STAT+: Richard Pazdur, longtime cancer regulator, named drug center director at FDA
STAT+: Richard Pazdur, longtime cancer regulator, named drug center director at FDA WASHINGTON — The Food and Drug Administration on Tuesday named Richard Pazdur, its longtime overseer of cancer therapies, as its top drug regulator. Pazdur replaces former Center for Drug Evaluation and Research Director George Tidmarsh, who exited the agency earlier this month amid…
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STAT+: At ‘hush-hush’ MAHA summit, RFK Jr. and deputies to mix with biotech leaders
STAT+: At ‘hush-hush’ MAHA summit, RFK Jr. and deputies to mix with biotech leaders WASHINGTON — Health secretary Robert F. Kennedy Jr. and many top deputies are scheduled to speak alongside industry executives and health activists at a daylong MAHA event on Wednesday that has not been publicly disclosed by administration officials or event organizers.…
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FDA reverses decades-old warning on hormone therapy products for menopause
FDA reverses decades-old warning on hormone therapy products for menopause WASHINGTON — The Food and Drug Administration is reversing a 2003 decision that put a stringent warning on hormone therapy products for menopausal women, saying that the treatments offer heart, brain, and bone health benefits. Commissioner Marty Makary wrote in a Wall Street Journal op-ed…
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STAT+: FDA broadens search for new top drug regulator after early setbacks
STAT+: FDA broadens search for new top drug regulator after early setbacks WASHINGTON — The Food and Drug Administration is struggling to select a new head of its drug center after the sudden and chaotic exit of the previous director, George Tidmarsh. Richard Pazdur, the director of the FDA’s Oncology Center for Excellence, was approached about…
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Melodrama at the FDA and the Pfizer-Novo bidding war
Melodrama at the FDA and the Pfizer-Novo bidding war On this week’s episode of “The Readout LOUD”: “Mean Girls” melodrama at the top of the FDA and the latest on the Pfizer-Novo Nordisk bidding war for Metsera. On a jam-packed show, your co-hosts, minus the vacationing Allison DeAngelis, chat with STAT’s D.C. correspondent Lizzy Lawrence…
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STAT+: FDA announces next round of priority review vouchers
STAT+: FDA announces next round of priority review vouchers WASHINGTON — The Food and Drug Administration on Thursday announced the second batch of companies being granted a “Commissioner’s National Priority Voucher,” a ticket to speedier reviews of drug candidates aligned with U.S. priorities. The announcement came as the Trump administration unveiled agreements with Eli Lilly and…
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Opinion: A sports device to ‘protect the brain’ illustrates a major problem with the FDA de novo pathway
Opinion: A sports device to ‘protect the brain’ illustrates a major problem with the FDA de novo pathway The Q-Collar — a neck collar inspired by the woodpecker — has been worn by NFL players and thousands of young athletes. When it debuted in 2012, it originally promised to reduce concussion risk by lightly squeezing the…
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STAT+: FDA’s top drug regulator placed on leave amid investigation
STAT+: FDA’s top drug regulator placed on leave amid investigation WASHINGTON — George Tidmarsh, the Food and Drug Administration’s top regulator of drugs, has been placed on administrative leave after being accused of using his regulatory authority to inflict financial harm on a former business associate, STAT has learned. FDA Commissioner Marty Makary relieved Tidmarsh of…
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STAT+: FDA moves to ease path for biosimilars as Trump seeks to cut drug costs
STAT+: FDA moves to ease path for biosimilars as Trump seeks to cut drug costs WASHINGTON — The Trump administration announced a draft framework Wednesday that officials say will speed cheaper versions of biologic drugs to market with the aim of making medicine more affordable and accessible for patients. The framework will shorten the path…
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STAT+: Casey Means faces confirmation hearing for surgeon general
STAT+: Casey Means faces confirmation hearing for surgeon general You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. The wife and I went to the Rehoboth Beach Sea Witch Festival dressed as a…
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STAT+: How the first nine drug companies won priority review vouchers from Marty Makary’s FDA
STAT+: How the first nine drug companies won priority review vouchers from Marty Makary’s FDA WASHINGTON — Commissioner Marty Makary wants the Food and Drug Administration to move more quickly. The launch of a new priority review voucher program in June was no exception. The agency promised winners a one- to two-month review of their drug…
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Startups push the FDA and biotech booms in North Carolina
Startups push the FDA and biotech booms in North Carolina Can Trump take credit for North Carolina’s booming biopharma industry? Which drugs could get a shortcut to the market? And who wore a tuxedo to the STAT Summit? We discuss all that and more in the latest episode of “The Readout LOUD.” Read the rest……
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STAT+: FDA review of drugs is slowing while application delays are growing, analysis finds
STAT+: FDA review of drugs is slowing while application delays are growing, analysis finds The upheaval at the Food and Drug Administration appears to be taking a toll on the pharmaceutical industry, according to a new analysis of key agency metrics. There was a significant drop in drug approvals in the recently ended third quarter,…
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STAT+: Biotech leaders say uncertainty at FDA threatens drug development
STAT+: Biotech leaders say uncertainty at FDA threatens drug development BOSTON — Replimune Group and Capricor Therapeutics both seemed on track to receive long-awaited drug approvals from the Food and Drug Administration earlier this year. Then, amid tumult at the agency as the Trump administration took power, their applications were rejected. The companies’ CEOs talked…
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STAT+: CEO of GSK plays down its role in FDA effort to approve therapy for autism-related condition
STAT+: CEO of GSK plays down its role in FDA effort to approve therapy for autism-related condition BOSTON — The CEO of the drugmaker GSK on Wednesday said the company has had a minimal role in the Food and Drug Administration’s effort to update the prescribing information of a long-shelved drug so that it can…
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STAT+: Peter Marks, FDA vaccine regulator ousted by RFK Jr., joins Eli Lilly
STAT+: Peter Marks, FDA vaccine regulator ousted by RFK Jr., joins Eli Lilly WASHINGTON — Peter Marks, the former top vaccine regulator at the Food and Drug Administration, has joined Eli Lilly to oversee molecule discovery and infectious diseases — a move that quickly drew criticism for the revolving door between the agency and industry. Marks confirmed…
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FDA approves another generic abortion pill, prompting outrage from conservatives
FDA approves another generic abortion pill, prompting outrage from conservatives WASHINGTON — Federal officials have approved another generic version of the abortion pill mifepristone, a regulatory formality that quickly triggered pushback from anti-abortion groups and politicians aligned with the Trump administration. Drugmaker Evita Solutions announced on its website that the Food and Drug Administration signed off on its low-cost form…
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STAT+: Top FDA drug regulator’s unusual criticism of a therapy gets Wall Street wagging
STAT+: Top FDA drug regulator’s unusual criticism of a therapy gets Wall Street wagging Is George Tidmarsh, the Food and Drug Administration’s top regulator, trying to exact revenge on a prominent Wall Street investor after a run-in with him six years ago? It’s the question biotech investors were wagging about all Monday after Tidmarsh used…
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STAT+: Crinetics wins FDA approval for acromegaly drug, faces competition with Novartis and Ipsen
STAT+: Crinetics wins FDA approval for acromegaly drug, faces competition with Novartis and Ipsen SAN DIEGO — Crinetics Pharmaceuticals won Food and Drug Administration approval on Thursday for a drug for a rare and debilitating hormonal disorder — the company’s first approved product. But the treatment faces competition from pharma giants with blockbuster medicines already…
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Opinion: The U.S. government has jumped the public health shark
Opinion: The U.S. government has jumped the public health shark On Monday, President Trump, health secretary Robert F. Kennedy Jr., Centers for Medicare and Medicaid Studies Administrator Mehmet Oz, and other top officials at the National Institutes for Health and the Food and Drug Administration presented their promised conclusions regarding the cause and treatment of…
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STAT+: FDA brings back GSK’s leucovorin drug that RFK Jr. touted as autism treatment
STAT+: FDA brings back GSK’s leucovorin drug that RFK Jr. touted as autism treatment In a highly unusual move, the Food and Drug Administration reapproved a drug on Monday that stopped being sold more than 25 years ago, part of a push from the Trump administration to identify the causes of and potential treatments for…
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Opinion: 9 answers to burning questions about pharmaceutical ads
Opinion: 9 answers to burning questions about pharmaceutical ads This article first appeared in the newsletter Your Local Epidemiologist.Pharmaceutical ads in the United States are annoying. Absurd. And almost uniquely American. In fact, only one other high-income country in the entire world — New Zealand — allows prescription drug companies to advertise directly to consumers.…
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FDA leaders moving to abandon advisory committee reviews of specific new drugs
FDA leaders moving to abandon advisory committee reviews of specific new drugs FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency’s decisions from public scrutiny. The agency “would like to get away” from assembling panels…
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STAT+: FDA will convene an advisory committee to tackle AI mental health device regulation
STAT+: FDA will convene an advisory committee to tackle AI mental health device regulation The Food and Drug Administration will convene experts to discuss challenges around regulating mental health products that use artificial intelligence, as a growing number of companies release chatbots powered by large language models whose output can be unpredictable. The move suggests…
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STAT+: An API supplier in India wants you to know its metal detector is working just fine
STAT+: An API supplier in India wants you to know its metal detector is working just fine For those wondering about any metallic particles found in active pharmaceutical ingredients made by a supplier called Hikal, you can rest easy — the company says its metal detector is working again. Since 2020, nearly two dozen complaints…
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STAT+: Former top FDA digital leader lands at Mayo Clinic
STAT+: Former top FDA digital leader lands at Mayo Clinic Sonja Fulmer, who recently left her role as a top digital health official at the Food and Drug Administration, last week started a new position focused on health tech policy at the Mayo Clinic. She is the second top health regulator to land at the…
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STAT+: Vaccine policy threatens to put Kennedy at odds with Trump
STAT+: Vaccine policy threatens to put Kennedy at odds with Trump WASHINGTON — Health secretary Robert F. Kennedy Jr.’s aggressive moves to change U.S. vaccine policy — adopted by leaders at other federal health agencies — may be putting him at odds with President Trump himself. Now Kennedy’s allies are rallying to support him, believing…
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STAT+: FDA will convene Digital Health Advisory Committee in November
STAT+: FDA will convene Digital Health Advisory Committee in November The Food and Drug Administration will convene a meeting of external digital health advisors on Nov. 6, according to an email reviewed by STAT. The gathering comes as the agency wrestles with myriad issues related to regulating artificial intelligence and other technologies in health care.…
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LSD can help reduce anxiety, new study finds
LSD can help reduce anxiety, new study finds LSD reduced symptoms of anxiety in a midstage study published Thursday, paving the way for additional testing and possible medical approval of a psychedelic drug that has been banned in the U.S. for more than a half century. The results from drugmaker Mindmed tested several doses of LSD in patients…
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STAT+: Amneal Pharma is scolded by FDA for using contaminated bags for a sterile injectable drug
STAT+: Amneal Pharma is scolded by FDA for using contaminated bags for a sterile injectable drug In a startling failure of quality control, Amneal Pharmaceuticals relied on contaminated bags for a sterile injectable drug even after identifying the risk and then lowered its standards so that the bags could continue to be used, according to…
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FDA issues narrower approvals for Covid boosters, revokes emergency authorizations
FDA issues narrower approvals for Covid boosters, revokes emergency authorizations WASHINGTON — The Food and Drug Administration on Wednesday approved updated Covid boosters, but removed emergency use authorizations for the vaccines, in a set of moves that could make the shots more difficult to obtain for children under 5, in particular. The moves were announced…
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HHS moves to strip thousands of federal health workers of union rights
HHS moves to strip thousands of federal health workers of union rights NEW YORK — The U.S. Department of Health and Human Services has moved to strip thousands of federal health agency employees of their collective bargaining rights, according to a union that called the effort illegal. HHS officials confirmed Friday that the department is…
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STAT+: FDA says it will publish reports of adverse events tied to drugs on daily basis
STAT+: FDA says it will publish reports of adverse events tied to drugs on daily basis WASHINGTON — The Food and Drug Administration announced Friday that it has begun publishing reports of adverse events concerning drugs and biological products on a daily basis. Previously, the database of the reports, called the FDA Adverse Event Reporting…
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STAT+: Major U.S. drug manufacturing plant did not properly investigate cat hair, pests, and other problems, FDA finds
STAT+: Major U.S. drug manufacturing plant did not properly investigate cat hair, pests, and other problems, FDA finds Cat hair, pests, bacteria, and equipment failures. These were among the concerns of a recent regulatory inspection of a key, but historically troubled, manufacturing plant that Novo Nordisk bought last year as part of its parent company’s…
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STAT+: Conflicts among CDC and FDA vaccine panel members are not as numerous as you think, study finds
STAT+: Conflicts among CDC and FDA vaccine panel members are not as numerous as you think, study finds Conflicts of interest on federal government vaccine panels have declined to “historically low levels” in recent years according to a new study, findings that are likely to increase debate over a contentious issue pushed by Health and…
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STAT+: Novo Nordisk’s obesity drug Wegovy cleared to treat MASH
STAT+: Novo Nordisk’s obesity drug Wegovy cleared to treat MASH Novo Nordisk’s obesity drug Wegovy was cleared by U.S. regulators on Friday to treat an increasingly common liver disease, adding to the list of conditions for which the blockbuster therapy is now approved. The Food and Drug Administration granted accelerated approval to Wegovy for patients…
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Vinay Prasad’s return, animal testing alternatives, and mRNA upended
Vinay Prasad’s return, animal testing alternatives, and mRNA upended Have investors soured on mRNA biotechs? How will Vinay Prasad approach his role at the Food and Drug Administration the second time around? And how do you pronounce “bronchiectasis”? We address all that and more on this week’s episode of “The Readout LOUD.” We discuss the…
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STAT+: Insmed’s lung disease drug approved in the U.S.
STAT+: Insmed’s lung disease drug approved in the U.S. Insmed on Tuesday received Food and Drug Administration clearance for the first treatment for a chronic lung disease, opening the biotech up to what could be a multibillion-dollar product. Insmed will sell the daily pill, brensocatib, under the brand name Brinsupri for bronchiectasis. The approval comes…
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STAT+: Prasad returns to the FDA, Attack on the CDC
STAT+: Prasad returns to the FDA, Attack on the CDC You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. Normally I keep the intro to this newsletter light-hearted. But today I feel compelled…
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STAT+: Dear Vinay: Please embrace dissent and fade into the background
STAT+: Dear Vinay: Please embrace dissent and fade into the background Dear Vinay: My editors asked me to explain your return to the Food and Drug Administration to readers. But I’m more interested, right now, in giving advice to you. Look, any claim I have to clairvoyance is void. I was surprised as anyone by…
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STAT+: Vinay Prasad returns to the FDA, weeks after his ouster
STAT+: Vinay Prasad returns to the FDA, weeks after his ouster WASHINGTON — Vinay Prasad is returning to the Food and Drug Administration to resume his role overseeing vaccine, gene therapy, and blood product regulation. “At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” Health and…
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In internal FDA town hall, employees raise concerns about staffing, impromptu expert meetings
In internal FDA town hall, employees raise concerns about staffing, impromptu expert meetings WASHINGTON — Top drug regulator George Tidmarsh assured Food and Drug Administration staff this week that he and other leaders are trying to bring operations back to normal. “I know that I’m coming in here at a challenging time,” Tidmarsh said at…
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STAT+: Unpacking Trump’s approach to health care oversight
STAT+: Unpacking Trump’s approach to health care oversight You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. I was reminded recently of why I dig mass transit upon overhearing the train conductor and…
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STAT+: Sarepta hired a Trump-connected firm to lobby on Duchenne treatment
STAT+: Sarepta hired a Trump-connected firm to lobby on Duchenne treatment WASHINGTON — Sarepta Therapeutics, which has come under regulatory pressure over its gene therapy for Duchenne muscular dystrophy, hired a Trump-connected lobbying firm after the death of a teenage boy treated with the drug, according to lobbying disclosure reports. Continue to STAT+ to read…
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Opinion: STAT readers debate involuntary commitment, Sarepta, and more
Opinion: STAT readers debate involuntary commitment, Sarepta, and more First Opinion is STAT’s platform for interesting, illuminating, and provocative articles about the life sciences writ large, written by biotech insiders, health care workers, researchers, and others. To encourage robust, good-faith discussion about issues raised in First Opinion essays, STAT publishes selected Letters to the Editor…
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FDA to stress opioids’ risk of overdose, death in new medication safety labels
FDA to stress opioids’ risk of overdose, death in new medication safety labels The Food and Drug Administration will soon require prescription opioid manufacturers to include stronger language on the medications’ labels warning that higher doses and longer-term use carry risks including overdose and death. The action, announced Thursday, comes nearly three months after a…
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What Vinay Prasad’s ouster means for biotech and the FDA
What Vinay Prasad’s ouster means for biotech and the FDA This week’s show is focused on a single topic — the ouster of Food and Drug Administration official Vinay Prasad from his job running the agency’s biologics division. This surprising development came after a series of controversial decisions he made on Sarepta’s gene therapy for…
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Opinion: Vinay Prasad is my former student and friend. His departure from FDA is a loss for American medicine
Opinion: Vinay Prasad is my former student and friend. His departure from FDA is a loss for American medicine A version of this piece first appeared in Sensible Medicine. Vinay Prasad, Marty Makary, and Adam Cifu, among others, were founding members of Sensible Medicine. After news came out that Vinay Prasad would be leaving the…
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STAT+: Vinay Prasad was not good for the FDA. But his ouster makes things worse
STAT+: Vinay Prasad was not good for the FDA. But his ouster makes things worse Vinay Prasad’s three-month tenure as one of the top officials at the Food and Drug Administration was bad for medicine. But his forced departure is probably worse. It will likely be celebrated in many corners: by the many people who…
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STAT+: Inside the fall of Vinay Prasad at the FDA
STAT+: Inside the fall of Vinay Prasad at the FDA Vinay Prasad had a problem. Several, actually. His staff at the Food and Drug Administration kept leaking to the press. He was under attack by President Trump’s allies after moving to pull a gene therapy off the market. Democrats were not happy with his Covid…
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Safety of fluoride supplements, and freedom of choice, debated at FDA meeting
Safety of fluoride supplements, and freedom of choice, debated at FDA meeting As Robert F. Kennedy Jr. has advocated for the removal of fluoride from water, he has framed it as an issue of medical freedom. “We shouldn’t be demanding that parents accept something for their children and in their homes that is essentially a…
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STAT+: For many Duchenne families, halt to gene therapy is heartbreak upon heartbreak
STAT+: For many Duchenne families, halt to gene therapy is heartbreak upon heartbreak Jennifer Hill Blair recognized the Cincinnati number on her buzzing phone and slipped out of the school meeting, excited to finally learn when her son Cayse would receive a therapy she believed would change his life. Blair, a second-grade teacher in southern…
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STAT+: FDA’s new top drug regulator hails from industry
STAT+: FDA’s new top drug regulator hails from industry You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. I scream! You scream! We all scream for ice cream without artificial dyes! Tell us…
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STAT+: Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says
STAT+: Sarepta Therapeutics’ Duchenne therapy faces ‘arduous’ path back to market, senior FDA official says Sarepta Therapeutics, the maker of a gene therapy for Duchenne muscular dystrophy that is being temporarily shelved because of safety concerns, faces an “arduous and treacherous path” to try to get it back onto the market, a senior Food and…
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Opinion: A sloppy report on mifepristone is being used to undermine the FDA — and the biotech industry
Opinion: A sloppy report on mifepristone is being used to undermine the FDA — and the biotech industry For decades, the Food and Drug Administration has partnered with clinicians and industry to deliver evidence-based medical innovations using a gold-standard framework for drug development and oversight. The agency has the authority to review any approved drug,…