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Phase 3 Trials

Efficacy Studies Eli Lilly Trials Drug Efficacy Efficacy and Safety C-POST Trial Eli Lilly DESTINY-Breast09 Trial Lecanemab SCORPIO-PEP Trial HER2CLIMB-05 Trial

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

Phase 3 data showed lower disease activity with safety matching the IV form.

EMA Panel Recommends Redemplo for Familial Chylomicronaemia Syndrome

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

Xenon Presents Phase 3 Azetukalner Results and 48‑Month Data at American Academy of Neurology Meeting

Revolution Medicines Drug Nearly Doubles Survival in Phase 3 Pancreatic Cancer Trial

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

Evolocumab Cuts First Cardiovascular Events by 31% in High‑Risk Diabetes Without Known Atherosclerosis

Pfizer, Valneva Seek Approval for Lyme Vaccine After >70% Efficacy in Phase 3

Pfizer–Valneva Lyme Vaccine Shows Over 70% Efficacy but Misses Primary Endpoint

FDA Approves First Therapy for Acquired Hypothalamic Obesity, Expanding Rhythm’s Imcivree

FDA Clears J&J’s Icotyde, First Oral IL-23 Psoriasis Therapy for Ages 12 and Up

uniQure Soars 36% After FDA Biologics Chief Vinay Prasad Announces April Exit

FDA Approves Sotyktu for Active Psoriatic Arthritis as First TYK2 Inhibitor

Lilly’s Oral GLP-1 Orforglipron Tops Oral Semaglutide in Lancet Phase 3 Diabetes Trial

FDA Approves Dupixent as First Treatment for Allergic Fungal Rhinosinusitis

FDA Approves First All-Oral, Fixed-Duration First-Line CLL/SLL Regimen: Calquence Plus Venetoclax

FDA Grants Priority Review to Otsuka’s ADHD Drug Centanafadine With July 24 Decision Date

FDA Grants Priority Review to Leqembi Autoinjector for Weekly At-Home Starting Dose

Moderna–Merck Personalized Melanoma Vaccine Sustains 5-Year Benefit, Cutting Recurrence Risk by 49%

FDA Grants Priority Review to Vera's Atacicept for IgA Nephropathy