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

Moderna noted the FDA did not identify any specific safety concerns with the vaccine and that the rejection was inconsistent ...

SHELTON, CONNECTICUT / ACCESS Newswire / February 10, 2026 / NanoViricides, Inc., a publicly traded company (NYSE ...

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 trial will be conducted at up to seven US sites, enrolling 90 patients with advanced or metastatic solid tumours.

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

Oveporexton is designed to promote wakefulness and reduce abnormal REM-sleep-like phenomena, including cataplexy, in patients with NT1.

Feb 9 (Reuters) - Regenxbio said on Monday the U.S. Food and Drug Administration had declined to approve its gene therapy for ...