Industry Dynamics

Industry News

03-28

2025

FDA approval for oral Fabhalta® (iptacopan) - the first and only treatment approved in C3 glomerulopathy

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……

03-17

2025

FDA Acceptance of New Drug Application for SYD-101 for the Treatment of Progression of Pediatric Myopia

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 ……

02-28

2025

The Food and Drug Administration (FDA) announced the end of the shortage of Wegovy and Ozempic

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……

02-10

2025

FDA approves Ozempic® (semaglutide) as the only GLP-1 RA to reduce the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease

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 ……

01-24

2025

FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer

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……

01-24

2025

Eisai and Biogen Announce FDA Acceptance of LEQEMBI® Application for Early Alzheimer’s Disease Treatment

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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