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Phase 3 Trials

Efficacy Studies Eli Lilly Trials Drug Efficacy C-POST Trial Lecanemab DESTINY-Breast09 Trial HER2CLIMB-05 Trial EMBER-3 Trial Brensocatib Clinical Trial EPCORE FL-1 Trial

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

The decision follows a late-stage study that showed a 15.8% BMI reduction at 52 weeks compared with a 2.6% increase on placebo.

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

Alumis TYK2 Pill Hits Phase 3 Goals in Psoriasis as Stock Jumps and $175 Million Offering Is Planned

FDA Grants Priority Review to Axsome’s AXS-05 for Alzheimer’s Agitation, Sets April 30 PDUFA Date

Cosmo’s Clascoterone Meets Phase III Goals in Male-Pattern Baldness Trials

FDA Approves Aqvesme for Thalassemia Anemia, First U.S. Therapy for Both Patient Groups

Novo Nordisk Files FDA Application for Weekly CagriSema Obesity Shot as GLP-1 Competition Intensifies

Takeda’s AI-Assisted Psoriasis Pill Succeeds in Phase 3, Outperforms Otezla

FDA Approves Rybrevant Faspro, a 5‑Minute Subcutaneous Amivantamab for EGFR‑Mutated Lung Cancer

FDA Clears Enhertu-Perjeta Combo for First-Line HER2-Positive Metastatic Breast Cancer

FDA Grants National Priority Voucher to J&J’s Tecvayli–Darzalex Combo in Multiple Myeloma