FDA officials say the assistant is flawed, just as the Trump administration stresses AI adoption in healthcare.

While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience ...

The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...

Discovered and developed by Sarepta Therapeutics, Elevidys is a gene therapy that won accelerated approval in June 2023 and ...

The Health and Human Services chief and the growing authoritarianism within the department are already seeding future danger.

MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) has expanded its Retina Scientific Advisory Board (SAB) and executive leadership team as the company accelerates toward filing three Biologics License ...

Replimune stock cratered Tuesday after the Food and Drug Administration unexpectedly rejected its experimental melanoma ...

Sarepta Therapeutics’ stock has dropped precipitously as questions swirl around the safety of its gene therapies. Meanwhile, the Duchenne patient community fears losing access to Elevidys while the ...

The FDA on Tuesday rejected a skin therapy from Replimune Group, suggesting a hardened stance on drug approvals under new agency officials ...

BMO Capital Markets pointed to FDA leadership, and CBER Director Vinay Prasad in particular, as potential factors in the ...

Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based ...