The head of the agency’s vaccine division, Vinay Prasad, has overruled pushback from career staffers.

It’s rare that FDA refuses to file an application, particularly for a new vaccine, which requires companies and FDA staff to ...

The Food and Drug Administration refused to review Moderna’s application for its new mRNA flu vaccine — a move the pharma ...

Prescription Drug User Fee Act (PDUFA) target action date set for September 28, 2026If approved, Ameluz® would be the first and only PDT ...

Senior FDA official Vinay Prasad reportedly overrode his staff in deciding to reject Moderna's application for a new seasonal flu shot.

The news is the latest sign of the FDA’s heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr.

Moderna said the move is inconsistent with previous feedback from the FDA on the experimental influenza shot, called ...

News is latest sign of the agency's heightened scrutiny of vaccines ...

The FDA is expected to review drug approval decisions in March 2026, including a treatment for psoriatic arthritis.

A gene therapy that patients breathe in has been found to shrink lung tumours by inserting immune-boosting genes into ...