Acadia Pharmaceuticals’ DAYBUE™ (trofinetide) Receives FDA Approval for Rett Syndrome Treatment
Neuren Pharmaceuticals has announced that its North American partner, Acadia Pharmaceuticals, has been granted FDA approval for the use of DAYBUE™ (trofinetide) in treating Rett syndrome among pediatr ...
FDA Approves Kevzara® (Sarilumab) for Treating Polymyalgia Rheumatica (PMR)
Regeneron Pharmaceuticals, Inc. and Sanofi have received FDA approval for Kevzara® (sarilumab) to treat polymyalgia rheumatica (PMR) in adult patients who have not responded well to corticosteroids or ...
FDA Approves Apellis’ SYFOVRE™ (pegcetacoplan injection) for Geographic Atrophy (GA)
Apellis Pharmaceuticals, Inc. announced today that SYFOVRE™ (pegcetacoplan injection) has been approved by the United States Food and Drug Administration (FDA) for the treatment of geographic atrophy ...
FDA Approves TEZSPIRE® for Self-Administration in Severe Asthma Patients Aged 12+
Amgen and AstraZeneca announced today that TEZSPIRE® (tezepelumab-ekko) has received approval from the U.S. FDA for self-administration in a pre-filled, single-use pen for severe asthma patients aged ...
FDA Grants Orphan-Drug Exclusivity to Recorlev® for Endogenous Cushing’s Syndrome Treatment
Xeris Pharmaceuticals has revealed that the FDA has awarded orphan-drug exclusivity for its drug Recorlev® (levoketoconazole) for treating adult patients with endogenous Cushing's syndrome for whom su ...