GlobalData on MSN2d
FDA approves Mirum’s Ctexli for cerebrotendinous xanthomatosis
Mirum Pharmaceuticals’ Ctexli (chenodiol) has gained US Food and Drug Administration (FDA) approval for treating adults with ...
Healio4d
FDA clears investigational new drug application for Zabalafin Hydrogel
The investigational new drug application for Zabalafin Hydrogel for the treatment of mild to moderate atopic dermatitis has ...
Cure Today15h
FDA Accepts NDA For Dordaviprone in H3 K27M-Mutant Diffuse Glioma
A New Drug Application has been accepted seeking accelerated approval for dordaviprone for patients with recurrent H3 ...
Targeted Oncology1d
FDA Clears IND Application for LTZ-301 in non-Hodgkin Lymphoma
The FDA cleared the investigational new drug application for LTZ-301, a first-in-class myeloid engager immunotherapy, with a ...
FDA accepts Teva & Medincell’s UZEDY sNDA for extended-release to treat BP-I
Teva Pharmaceuticals (TEVA) and Medincell (MEDCL) announced that the supplemental New Drug Application sNDA for UZEDY extended-release ...
FDA Grants Orphan Drug Designation to Revolutionary Cystic Fibrosis Therapy
Porosome Therapeutics, Inc. announced the Orphan Drug Designation of its cystic fibrosis therapy by the Food and Drug Administration (FDA).
Teva, Medincell announce FDA acceptance of sNDA for Uzedy
Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, and Medincell announced that the supplemental New Drug ...
Investing15h
FDA accepts Teva, Medincell's supplemental application for UZEDY as bipolar I disorder treatment
UZEDY is currently approved for use every one or two months as a subcutaneous long-acting injectable (LAI) for the treatment ...
FDA accepts Teva's application for Uzedy for bipolar I disorder
The FDA has accepted a supplemental New Drug Application submitted by Teva (NYSE:TEVA) and Medincell (OTC:MDCLF) for Uzedy ...
Harmony Biosciences stock falls after FDA rejects Wakix expansion
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Contract Pharma6d
PTC’s FA Drug Vatiquinone Gets FDA Priority Review
The U.S. Food and Drug Administration (FDA) has accepted for filing PTC Therapeutics’ New Drug Application (NDA) for ...