STAT+: FDA rejection is a reality check on agency rhetoric

STAT News · Feb 26, 2026 · Collected from RSS

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Sarepta CEO steps down, an experimental cell therapy rejection, and more biotech news

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Sarepta CEO steps down, an experimental cell therapy rejection, and more biotech news Manuel Balce Ceneta/AP Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. The FDA’s recent rejection of a rare disease cell therapy — despite prior internal support and an approval in Europe — is prompting questions about whether the agency’s rhetoric matches its regulatory actions under the new leadership. Also, an independent researcher outlines why clinical trials of supplements are so very flawed, and we delve into a looming epilepsy data readout. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in View All Plans To read the rest of this story subscribe to STAT+. Subscribe Biotech Correspondent Meghana Keshavan covers biotech and contributes to The Readout newsletter.

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STAT Newsabout 2 hours ago

STAT+: FDA Commissioner Marty Makary defends rare disease drug rejections, Vinay Prasad

FDA Commissioner Marty Makary defended the agency’s recent rejections of rare disease drugs and one of his deputies, Vinay Prasad, in an interview with CNBC.

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STAT+: FDA rejection is a reality check on agency rhetoric

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STAT Newsabout 2 hours ago
STAT+: FDA Commissioner Marty Makary defends rare disease drug rejections, Vinay Prasad
FDA Commissioner Marty Makary defended the agency’s recent rejections of rare disease drugs and one of his deputies, Vinay Prasad, in an interview with CNBC.

STAT Newsabout 4 hours ago
STAT+: Pharmalittle: We’re reading about a puzzling FDA rejection, a Lilly weight loss pill, and more
An experimental therapy for a rare blood cancer was rejected by the FDA though internal reviewers had recommended it be cleared

STAT Newsabout 5 hours ago
Questions on the agenda for ACIP’s next meeting
Casey Means faces off against Cassidy, a postponed vaccine advisory meeting, and more health news

STAT Newsabout 6 hours ago
STAT+: Xenon’s seizure drug study reads out soon. Here’s what to expect
Xenon Pharmaceuticals is developing a drug for the most common type of seizure experienced by people with epilepsy. Here's what to know.

STAT Newsabout 8 hours ago
Opinion: I tried to design a clinical trial for a supplement. 5 things got in the way
When Elise Felicione tried to design a clinical trial for a supplement, 5 things got in the way. It’s a lesson for the industry.

STAT Newsabout 8 hours ago
Brain implants: What’s standing in the way of pivotal trials, FDA approval
Thirty years after scientists demonstrated how brain implants can help rhesus monkeys move robotic limbs using only their mind, the clinical pathway for the technology is still a little out…