Merck Ifinatamab Deruxtecan BLA Withdrawn in Previously Treated ES-SCLC
Merck and Daiichi Sankyo have voluntarily withdrawn the U.S. Biologics License Application for ifinatamab deruxtecan in certain patients with previously treated extensive-stage small cell lung cancer after discussions with the FDA indicated that the submitted data did not meet the requirements for accelerated approval.
Eli Lilly Olumiant Alopecia Areata Treatment Approved by FDA for Pediatric Patients 12 and Older
Lilly Olumiant Alopecia Areata has received FDA approval for pediatric patients 12 and older, expanding treatment access based on Phase 3 BRAVE-AA-PEDS trial results showing substantial scalp hair regrowth in adolescents with severe alopecia areata.
Lilly Onswik FDA Approval: Eli Lilly’s Weekly Basal Insulin Clears FDA for Type 2 Diabetes
The FDA has approved Eli Lilly’s Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin for adults with type 2 diabetes. Backed by the QWINT Phase 3 program spanning over 3,400 patients, Onswik becomes Lilly’s fourth global approval for the weekly insulin, expected to launch via the KwikPen in the coming months.
J&J TECVAYLI DARZALEX FASPRO Survival Data Redefine Long-Term Outlook in Early Multiple Myeloma Relapse
New MajesTEC-3 modeling from Johnson & Johnson finds that TECVAYLI plus DARZALEX FASPRO, used as early as second line, could give roughly 87% of relapsed/refractory multiple myeloma patients a mortality risk and life expectancy close to the general population, driven by a 90% drop in disease-progression risk versus standard of care.
Johnson & Johnson CAPLYTA Bipolar Mania Study Shows Significant and Rapid Improvement
Johnson & Johnson has reported pivotal Phase 3 findings for CAPLYTA (lumateperone) in bipolar mania, with the study showing significant and rapid improvement in manic symptoms.
Novartis Cosentyx PMR Receives Positive CHMP Opinion for Polymyalgia Rheumatica in Europe
Novartis has received a positive CHMP opinion recommending European marketing authorization for Cosentyx (secukinumab) in adults with polymyalgia rheumatica, based on Phase III REPLENISH data showing sustained remission and steroid-sparing effects.
Novo Sogroya CHMP Opinion: EMA Recommends Once-Weekly Somapacitan for Idiopathic Short Stature
Novo receives a positive CHMP opinion for once-weekly Sogroya® (somapacitan) to treat children with idiopathic short stature in Europe.
Novo: FREHEMGO Haemophilia A Prophylaxis Wins Positive CHMP Opinion for EU Approval
Novo has secured a positive CHMP opinion for FREHEMGO® (denecimig) to treat haemophilia A in adults and children, offering the first FVIIIa mimetic with once-monthly, bi-weekly, and weekly dosing options in a pre-filled pen.
Clinical Trial Failures 2026: AstraZeneca, Novartis and Kyowa Kirin Report a Wave of Phase 2 and Phase 3 Setbacks
Three major drugmakers disclosed missed primary endpoints within days of each other in September 2026 — here’s what went wrong, who it affects, and what it signals about pharma R&D.
Charles River Laboratories Accelerates Drug Development with Charles River Rapid Cell Banking Platform
Charles River Laboratories launches its NGS-enabled rapid cell banking platform, cutting production timelines by 40% through automated rapid microbiological testing and in vitro characterization.