Porosome Therapeutics, Inc. announced the Orphan Drug Designation of its cystic fibrosis therapy by the Food and Drug Administration (FDA).

Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, and Medincell announced that the supplemental New Drug ...

A New Drug Application has been accepted seeking accelerated approval for dordaviprone for patients with recurrent H3 ...

The FDA has accepted a supplemental New Drug Application submitted by Teva (NYSE:TEVA) and Medincell (OTC:MDCLF) for Uzedy ...

Teva Pharmaceuticals (TEVA) and Medincell (MEDCL) announced that the supplemental New Drug Application sNDA for UZEDY extended-release ...

The FDA accepted for priority review a supplemental Biologics License Application for Keytruda for resectable locally ...

Gilead Sciences has announced the European Medicines Agency’s (EMA) validation for a parallel accelerated review of ...

The FDA cleared the investigational new drug application for LTZ-301, a first-in-class myeloid engager immunotherapy, with a ...

FDA clears LTZ's IND application to initiate trial of its myeloid engager immunotherapy to treat relapsed or refractory non-Hodgkin lymphoma.

The EMA is set to perform accelerated reviews of Gilead Sciences’ applications for its twice-yearly injectable for HIV ...

Last week, the lobbying group AdvaMed pushed back on the firings, calling on Health Secretary Robert F. Kennedy Jr. to ...

Ozempic and Wegovy, the widely popular forms of semaglutide sold to treat diabetes and obesity, have officially been removed ...