What Does the FDA's NDA Acceptance Mean for Mineralys Therapeutics

Mineralys Therapeutics announced the FDA accepted its New Drug Application for lorundrostat to treat hypertension in adults. The agency assigned a PDUFA target action date of December 22, 2026, markin...

ADMA Biologics shares are in focus after the FDA expanded the label for Asceniv to include younger patients. This regulatory approval broadens the drug's addressable market and strengthens the company...

The U.S. FDA launched a pilot program on Monday to monitor clinical trial data in real time. This initiative aims to accelerate drug approval timelines by years and maintain U.S.