Industry Dynamics

Industry News

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……

11-28

2024

U.S. FDA Approval for BIMZELX® (bimekizumab-bkzx) for Adults with Moderate-to-Severe Hidradenitis Suppurativa

November 22, 2024 – UCB announced that the U.S. Food and Drug Administration (FDA) has approved BIMZELX® (bimekizumab-bkzx) for the treatment of adults with moderate-to-severe hidradenitis suppurativa (HS).2 BI……

11-11

2024

Dupixent approved in the EU as the first and only medicine for young children with eosinophilic esophagitis

November 27, 2024 – Regeneron Pharmaceuticals and Sanofi announced that the European Medicines Agency has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one year of age. Spe……

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