Faster review times could leave drugmakers vulnerable to litigation, while new Trump administration priorities add more ...

FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

Based on the FDA’s safety database recommendations and our plan to request approval to treat a broad population of patients including adults and children, we now plan to submit our BLA seeking ...

The FDA now provides daily updates on adverse event reports for drugs and biologics via FAERS. Read more here.

Phase 3 clinical trial results from Scripps Research and its collaborators supported FDA approval of ENCELTO, the first ...

The sodium chloride 0.9 percent injection shortage is resolved, and it will be removed from the FDA Drug Shortage Database; facilities are advised to use FDA-approved products when available. The FDA ...

In the wake of mass restructuring efforts across the Department of Health and Human Services (HHS), the FDA has missed yet another approval decision target date. GSK had expected to secure an FDA ...

The U.S. Food and Drug Administration on Thursday approved Ionis Pharmaceuticals' drug to prevent instances of severe ...

Larimar Therapeutics outlines FDA recommendations for nomlabofusp BLA submission, targeting Friedreich’s Ataxia treatment by 2026.