The cuts hit the FDA's medical device center particularly hard, including reviewers and experts on AI-enabled medical ...

The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for ...

The US Food and Drug Administration (FDA) has approved Sanofi’s Merilog (insulin-aspart-szjj), a biosimilar to Novolog ...

As of Jan. 1, 2025, every company that sells baby food products in California is required to test for four heavy metals every ...

The Trump administration is tearing down both regulations and the federal government that enforces them. The consequences will be enormous.

Gilead Sciences has won Food and Drug Administration priority review for its proposed lenacapavir twice-yearly shot to prevent HIV. Gilead on Tuesday said an FDA green light would make lenacapavir the ...

Direct-to-consumer telehealth company advertisement that aired during the Super Bowl failed to mention side effects of the drugs.

The SSA acting commissioner stepped down over requests from DOGE to access data, while the FDA food division head left amid ...

The firm is seeking accelerated approval for UX111 using reductions in levels of heparan sulfate in cerebrospinal fluid as a surrogate endpoint.

Psoriasis was less likely to progress to psoriatic arthritis (PsA) among patients treated with interleukin-17 (IL-17) or ...

Former CDC Director Tom Frieden warns that cutting the Public Health Associate Program and Laboratory Leadership Service ...

Ultragenyx (RARE) announced the FDA has accepted for review the Biologics License Application, or BLA, seeking accelerated approval for UX111 ...