Peter Marks, the FDA’s top vaccine official ousted by Robert F. Kennedy Jr. said the U.S. health secretary’s team sought ...

Massive cuts at the FDA have hit staff tied to drug reviews and user fees, putting future approvals in jeopardy, according to multiple reports.

While it’s not unusual for certain positions to turn over with a new administration, the number of senior-level FDA staffers ...

The delay dovetails with moves by Republican lawmakers in at least seven states to ban or limit mRNA vaccines. Some, ...

Novo Nordisk is licensing a drug called LX9851 from Lexicon Pharmaceuticals for up to $75 million in upfront and near-term ...

The FDA was supposed to make a final decision about approval of Novavax's COVID-19 vaccine this week, but that deadline has ...

Amid a period of great upheaval at the agency, the FDA has missed its deadline to decide on approval for Novavax’s COVID-19 ...

Biotech stocks face a tough 2025 with SMid-cap losses up to 40% YTD. BofA cites FDA changes, tariffs, and capital struggles but notes potential opportunities.

Novavax's COVID-19 vaccine received FDA Emergency Use Authorization, but full approval faces delays as regulators request more data beyond the April 1 deadline.

President Trump yesterday announced a baseline tariff of 10% on all imported products and higher rates on certain countries ...

In an unusual move, top Trump FDA official Sara Brenner, MD, MPH, directly intervened in an agency review of Novavax's ...

The Food and Drug Administration had already indicated that it approved the vaccine, but new agency leaders are now requesting more data. Meanwhile, FDA staffers who oversaw expert panel meetings on ...