Applied Therapeutics, Inc. has announced an extension in the review period by the U.S. Food and Drug Administration for their New Drug Application for govorestat, intended for treating Classic Galactosemia

Milestone® Pharmaceuticals Inc, a biopharmaceutical company focusing on innovative cardiovascular medicines, has announced the resubmission of its New Drug Application

Renexxion Ireland Limited, in partnership with Dr. Falk Pharma GmbH in Europe, has obtained clearance from the U.S. Food and Drug Administration for its Investigational New Drug application concerning

IntraBio Inc announced today that the U.S. Food and Drug Administration has accepted its New Drug Application for IB1001, intended for treating Niemann-Pick disease Type C. The application

Amneal Pharmaceuticals, Inc. has announced that it received approval for its Abbreviated New Drug Application from the U.S. Food and Drug Administration for ciprofloxacin and dexamethasone

ULTOMIRIS® has recently obtained approval in the United States as the first and only long-acting C5 complement inhibitor for the treatment of adult patients diagnosed with anti-aquaporin-4

Molecure S.A. is a biotechnology company specializing in the development of innovative drugs for treating various incurable diseases. The company focuses on leveraging its expertise

Today, the U.S. Food and Drug Administration has approved Duvyzat, an oral medication, for treating Duchenne Muscular Dystrophy in patients aged six and above. Duvyzat is notable for being the first nonsteroidal drug

Cabaletta Bio, Inc. has recently gained Orphan Drug Designation from the U.S. Food and Drug Administration for its investigational therapy, CABA-201, aimed at treating systemic sclerosis

Puma Biotechnology, Inc., a biopharmaceutical company, has received approval from the U.S. Food and Drug Administration for its Investigational New Drug Application concerning alisertib. This allows Puma to progress with clinical trials