STAT+: FDA declines to approve Ultragenyx gene therapy

STAT+: FDA declines to approve Ultragenyx gene therapy










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Morning! It’s Meghana today, writing about GLP-1s being deployed for addiction, weighing the FDA commissioner’s vision versus reality, and more.

The need-to-know this morning

  • AstraZeneca said its experimental hypertension drug, baxdrostat, reduced treatment-resistant blood pressure in a late-stage clinical trial. The drug works by lowering blood pressure in a new way, different from currently available medicines. If approved, AstraZeneca has told investors baxdrostat could become a multibillion-dollar commercial product.

Makary’s big promises at FDA get a closer inspection

In his first 100 days as commissioner of the Food and Drug Administration, Marty Makary has made a handful of splashy announcements — from pledging transparency on rejection letters to floating fast-track vouchers for drugs tied to national health priorities.

Continue to STAT+ to read the full story…






Meghana Keshavan





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