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Drug Approval

FDA FDA Approval FDA Regulations Alzheimer's Disease Lecanemab FDA Approvals Cancer Treatment Clinical Trials Rare Diseases Alzheimer's Treatment

FDA Authorizes Early Access to Daraxonrasib for Pancreatic Cancer Patients

The decision follows trial results showing the oral drug roughly doubled survival versus chemotherapy.

FDA Approves Auvelity as First Non‑Antipsychotic for Alzheimer’s Agitation

FDA Panel Rejects AstraZeneca Breast Cancer Drug, Backs Prostate Therapy

FDA Clears Vepdegestrant, First PROTAC Cancer Drug, for ESR1‑Mutated Breast Cancer

FDA Clears Once-Weekly Saphnelo Pen for Self-Injection in Lupus

EU Drug Panel Backs Sanofi’s Cenrifki for Non‑Relapsing SPMS

FDA Clears Dupixent as First Biologic for Young Children With Chronic Spontaneous Urticaria

HHS Chief Distances From FDA Replimune Denial as Oncologists Dispute Review

FDA Expands Tzield Use to Delay Type 1 Diabetes in Children Ages 1 to 7

EMA Validates Astellas Bid to Add Padcev–Keytruda Combo for Perioperative Muscle-Invasive Bladder Cancer

FDA Orders Post-Approval Safety Studies for Lilly’s Foundayo Weight-Loss Pill

FDA Approves Filspari to Reduce Proteinuria in FSGS Patients Without Nephrotic Syndrome

FDA Rejects Replimune’s Melanoma Virus Therapy Again for Insufficient Evidence

ImmunityBio Faces Investor Suits After FDA Rebuke as Anktiva Sales Jump

India’s Generic Semaglutide Wave Eats Into Mounjaro’s Lead as Novo Holds Share

Insmed Halts Brensocatib in Hidradenitis Suppurativa After Phase 2b Trial Fails

FDA Clears Eli Lilly’s Foundayo Oral GLP-1 for Weight Loss, With U.S. Launch Set for April 6

FDA Clears Lilly’s Foundayo Pill, Escalating GLP-1 Weight-Loss Rivalry

FDA Approves Higher‑Dose Spinraza Regimen for Spinal Muscular Atrophy

FDA Approves Awiqli, First Once-Weekly Basal Insulin for Type 2 Diabetes