The US Food and Drug Administration (FDA) has approved Atzumi, a 5.2 mg dihydroergotamine (DHE) nasal powder, for the acute treatment of migraine with or without aura in adults. Developed by Satsuma ...

2 If approved ... are pleased that the FDA has accepted our submission and look forward to working with regulatory authorities on what would be the first oral GLP-1 treatment for obesity." ...

This week, the Food and Drug Administration approved gene-edited pigs developed by PIC, a biotechnology company specializing in livestock genetics, for human consumption. The FDA granted the ...

May 2, 2025 -- The FDA has approved a new treatment for generalized myasthenia gravis (gMG), a disease that causes severe muscle weakness, faster muscle fatigue, and difficulty in speaking and ...

The Jewel Patch Wearable Cardioverter Defibrillator. Credit: Element Science/Business Wire. The US Food and Drug Administration (FDA) has approved Element Science’s premarket approval application for ...

The Food and Drug Administration (FDA) has approved Rinvoq ® (upadacitinib), a Janus kinase (JAK) inhibitor, for the treatment of adults with giant cell arteritis (GCA). The approval was based on data ...

PLAINSBORO, N.J., May 2, 2025 /PRNewswire/ -- Today, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA ... 2 If approved, Wegovy ® would become the first oral formulation of a GLP ...

New York, April 30, 2025 (GLOBE NEWSWIRE) -- Muscular Dystrophy Association (MDA) applauds the U.S. Food and Drug Administration (FDA) approval of IMAAVY TM (nipocalimab-aahu) for the treatment of ...

SPRING HOUSE, Pa. - Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved IMAAVY™ (nipocalimab-aahu) for the treatment of generalized myasthenia gravis (gMG) ...

We look forward to continued collaboration with the FDA as we work to deliver this potentially paradigm-shifting treatment to patients ... data needed to support approval and for a rolling ...