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FDA Approves Isembyld, First Muscle‑Directed Therapy for Spinal Muscular Atrophy

Isembyld is an IV add‑on to existing SMN2 treatments that showed motor improvement in children and will begin U.S. shipments.

EMA Committee Recommends Revoking Tavneos Authorization

FDA Grants Accelerated Approval to Sanofi’s Tzield for Children With Stage 3 Type 1 Diabetes

Abivax Drug Shows Breakthrough Ulcerative Colitis Results as Shares Plunge After Cancer Cases

FDA Delays Two Drugs in National Priority Voucher Program After Safety, Efficacy Flags

AstraZeneca’s LATIFY Phase 3 Finds No Survival Benefit for Ceralasertib Plus Imfinzi in Pre-Treated NSCLC

Lilly’s Daily Obesity Pill Sustains Weight Loss After Switch From Wegovy or Zepbound

Nektar’s Alopecia Drug Misses Phase 2b Goal as Company Cites Ineligible Patients, Plans Phase 3

FDA Grants Full Approval to Jaypirca for Relapsed CLL/SLL After Covalent BTK Therapy

FDA Approves Poherdy as First Interchangeable Biosimilar to Perjeta for HER2-Positive Breast Cancer

FDA Reapproves GSK’s Blenrep for Multiple Myeloma in Narrow Combination Use

WCLC 2025: Combination Approaches Redraw EGFR-Mutant NSCLC Care

Amgen Advances Monthly Obesity Drug to Phase 3 After 20% Weight Loss in Mid-Stage Trial