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STAT+: Katherine Szarama named acting director of FDA’s vaccines and biologics center
WASHINGTON — The Food and Drug Administration has named Katherine Szarama as the acting director of the Center for Biologics Evaluation and Research, which regulates vaccines, gene therapies, and the blood supply.
A Health and Human Services official confirmed the move, which was first reported by Politico, to STAT.
She is replacing Vinay Prasad, who left the agency on Thursday after a tumultuous tenure during which he issued a series of controversial decisions on rare disease drugs and vaccines. FDA Commissioner Marty Makary said in March that Prasad would return to the University of California San Francisco.
WASHINGTON — The Food and Drug Administration has named Katherine Szarama as the acting director of the Center for Biologics Evaluation and Research, which regulates vaccines, gene therapies, and the blood supply.
A Health and Human Services official confirmed the move, which was first reported by Politico, to STAT.
She is replacing Vinay Prasad, who left the agency on Thursday after a tumultuous tenure during which he issued a series of controversial decisions on rare disease drugs and vaccines. FDA Commissioner Marty Makary said in March that Prasad would return to the University of California San Francisco.
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STAT+: Where ‘democracy met science,’ 50 years ago
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.
Good morning. At a Cambridge bar on Saturday, I watched straight-seeming couples congregate by a television showing basketball, while a more queer-coded crowd lingered at another showing soccer. I don’t think that’s anything, really, but it was fun.
This ‘never event’ is happening more frequently
A child born with congenital syphilis could suffer dire consequences: bone deformities, brain damage, blindness, deafness, and more. But that should be a ‘never event’ as public health officials say: A pregnant person can receive an injectable form of penicillin to prevent the infection. Somehow, rates keep going up anyway. Between 2012 and 2024, the U.S. saw an 800% increase in babies born with the disease. And since last year, there’s been a shortage of the drug.
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.
Good morning. At a Cambridge bar on Saturday, I watched straight-seeming couples congregate by a television showing basketball, while a more queer-coded crowd lingered at another showing soccer. I don’t think that’s anything, really, but it was fun.
This ‘never event’ is happening more frequently
A child born with congenital syphilis could suffer dire consequences: bone deformities, brain damage, blindness, deafness, and more. But that should be a ‘never event’ as public health officials say: A pregnant person can receive an injectable form of penicillin to prevent the infection. Somehow, rates keep going up anyway. Between 2012 and 2024, the U.S. saw an 800% increase in babies born with the disease. And since last year, there’s been a shortage of the drug.
Sanofi makes no mention of the Commissioner’s National Priority Voucher. Tzield was awarded the ticket in October 2025, but Sanofi requested withdrawal from the program after former CDER head Tracy Beth Høeg reportedly expressed skepticism of the drug.
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Rhythm’s obesity drug scores ‘better than expected’ weight loss in rare genetic disease
Rhythm’s obesity drug scores ‘better than expected’ weight loss in rare genetic disease
Rhythm Pharmaceuticals’ Imcivree reduced fat—while boosting muscle—in patients with Prader-Willi syndrome. Read More
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STAT+: Where ‘democracy met science,’ 50 years ago
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