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FDA

FDA Accepts Roche’s Tecentriq for Priority Review in dMMR Stage III Colon Cancer

Approval by October 9, 2026 would establish the first immunotherapy-based adjuvant option for patients with dMMR/MSI-H stage III colon cancer.

FDA Chief Makary Faces Intensifying Pressure as Vape Approvals and Staff Shake-Up Fuel Scrutiny

FDA Authorizes Early Access to Daraxonrasib for Pancreatic Cancer Patients

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

HHS Chief Distances From FDA Replimune Denial as Oncologists Dispute Review

Lilly’s Oral Foundayo Matches Insulin on Heart Safety in Major Diabetes Trial

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

FDA Approves First Glucocorticoid Receptor Blocker for Platinum-Resistant Ovarian Cancer

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

FDA Approves Leucovorin for Ultra-Rare FOLR1 Folate Disorder, Declines Autism Indication

FDA Biologics Chief Vinay Prasad to Step Down at End of April

Novo Nordisk Forecasts Up to 13% 2026 Sales and Profit Decline as U.S. Price Cuts Bite

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

FDA Approves Zycubo, First U.S. Treatment for Menkes Disease

Amazon Pharmacy Adds FDA-Approved Wegovy Pill With $25 Copays and Nationwide Delivery

FDA Approves First Oral GLP-1 for Obesity as Novo’s Wegovy Pill Sets January U.S. Launch

FDA Approves Wegovy Weight-Loss Pill as First Oral GLP-1 for Obesity

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

FDA Approves Durvalumab Added to Perioperative FLOT for Resectable Gastric and GEJ Cancer

FDA Approves Novartis’ Itvisma for SMA Patients Ages 2 and Up