STAT+: Khosla Ventures sets sights on $4 billion in new funds

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Hello, friends! We’re back. Hope you are having a delightful summer (or winter, I suppose, depending on your hemisphere). Today, we talk about morale at the FDA and potential fallout, see how the agency’s posture toward China could affect biotechs, and more.

The need-to-know this morning

• The FDA approved a pill from KalVista Pharmaceuticals that treats patients suffering from acute attacks of hereditary angioedema, a painful tissue-swelling disorder. The drug will be marketed under the brand name Ekterly.
• Cogent Biosciences reported results from a Phase 3 study of bezuclastinib in indolent systemic mastocytosis, the most common form of an immune system disorder that causes allergic-like skin reactions, gastrointestinal and neurological symptoms, fatigue, and generalized pain. 
• Jasper Therapeutics said it is investigating a potential manufacturing defect that may have caused its experimental drug briquilimab to lose potency and affect the results of a mid-stage clinical trial. 

FDA morale crisis deepens amid a staff exodus

About one in five FDA staffers were pushed out of the agency in April as part of the Trump administration’s cuts, and talent has continued to leave since then, tanking morale, STAT’s Lizzy Lawrence reports exclusively. Staffing shortages, political upheaval, and distrust in leadership are taking a toll on the FDA’s ability to regulate drugs, devices, and food.

Continue to STAT+ to read the full story…