Industry Dynamics

Industry News

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……

12-27

2024

FDA approves Alhemo for hemophilia bleeding prevention

December 20, 2024 -- Novo Nordisk announced that the FDA approved Alhemo (concizumab-mtci) injection as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 22 ……

12-13

2024

Lilly's Zepbound® (tirzepatide) superior to Wegovy® (semaglutide) in head-to-head trial

December 4, 2024 -- Eli Lilly and Company (NYSE: LLY) today announced topline results from the SURMOUNT-5 phase 3b open-label randomized clinical trial. Zepbound® (tirzepatide) provided a 47% greater relative weight loss……

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