The vaccine advisory committee is scheduled to meet next week to review and make recommendations for this fall’s updated ...

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...

The U.S. Food and Drug Administration has approved Johnson & Johnson's drug delivery system for a type of bladder cancer, ...

FDA Commissioner Marty Makary said publishing complete response letters recognizes public interest in the transparency and credibility of agency decision-making about drugs. He also said the move ...

The U.S. Food and Drug Administration has created a "green list" import alert to stop unapproved and unverified glucagon-like ...

BALA CYNWYD, Pa., June 23, 2025 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare ...

Larimar Therapeutics, Inc. has announced a refined timeline for submitting a Biologics License Application (BLA) for its treatment nomlabofusp, aimed at addressing Friedreich's Ataxia (FA). Based on ...

The US Food and Drug Administration approved updated Covid-19 vaccines but for a more limited group: adults age 65 and older ...