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FDA

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

Lower U.S. prices, intensifying competition, patent expiries prompted the downgrade.

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

FDA Adds Boxed Liver Warning and Limits Elevidys to Ambulatory Boys 4 and Up

FDA Names Richard Pazdur to Lead Drug Review Center

FDA Rejects Biohaven’s Vyglxia for Spinocerebellar Ataxia

FDA Approves Libtayo as First Immunotherapy for Adjuvant Treatment of High‑Risk CSCC

Perioperative Nivolumab Preserves Quality of Life in Resectable NSCLC, WCLC 2025 Data Show

Vinay Prasad Resigns as FDA Biologics Director After Politicized Tenure

Sotatercept cuts risk of death and hospitalization by 76% in advanced pulmonary arterial hypertension