On March 22, 2025--Novartis today announced that oral Fabhalta? (iptacopan) has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), to reduce prot……
On March 22, 2025, Sydnexis announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for SYD-202 and has assigned a Prescription Drug User Fee Act (PDUFA) target action date ……
February 24, 2025 -- The Food and Drug Administration announced Friday it had officially declared an end to the nationwide shortage of Ozempic and Wegovy, medications used for diabetes and weight loss.The agency first de……
On February 5, 2025, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved Ozempic to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death ……
On January 27, 2025, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for adult patients with unres……
January 23, 2025 -- Eisai and Biogen have announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for LEQEMBI? (lecanemab-irmb) subcutaneous autoinjector (SC-AI) fo……
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