Johnson & Johnson eyes FDA nod to icotrokinra after phase III studies show strong skin clearance and safety in plaque ...

Replimune Group Inc. shares sank to their lowest point ever after US regulators rejected a skin cancer treatment from the ...

Sotyktu (deucravacitinib) has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.

An FDA advisory panel concludes that the efficacy of brexpiprazole, when started concurrently with sertraline, has not been ...

The FDA granted an orphan drug designation to novel hedgehog pathway inhibitor taladegib, also known as ENV-101, for treating ...

The Food and Drug Administration (FDA) has granted Priority Review to TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder ...

These updates support Ocugen in its efforts to pursue its goal of 3 biologics license applications (BLA) in the next 3 years.

Princeton, New Jersey Tuesday, July 22, 2025, 12:00 Hrs [IST] ...

Bavarian Nordic A/S (OMX: BAVA) announced today that Health Canada has accepted for review the Company’s application for ...

The Supreme Court’s recent unanimous decision on FDA’s drug-approval authority is utterly unremarkable.