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

Mirum Pharmaceuticals’ Ctexli (chenodiol) has gained US Food and Drug Administration (FDA) approval for treating adults with ...

The investigational new drug application for Zabalafin Hydrogel for the treatment of mild to moderate atopic dermatitis has ...

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

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

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

Gilead pharmaceutical company announced today (Tuesday, Feb. 18) that the U.S. Food and Drug Administration has accepted the ...

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

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

UZEDY is currently approved for use every one or two months as a subcutaneous long-acting injectable (LAI) for the treatment ...