Tag Archives: FDA priority review

FDA Grants Priority Review to Imfinzi for First‑Ever Perioperative Immunotherapy in Resectable Gastric and GEJ Cancer

(IN BRIEF) The FDA has accepted AstraZeneca’s sBLA for Imfinzi as a perioperative immunotherapy regimen in resectable early‑stage and locally advanced gastric and GEJ cancers, granting Priority Review with a decision expected in Q4 2025. The application leverages MATTERHORN Phase III data … Read the full press release

Sanofi’s Dupixent Receives FDA Priority Review for the Treatment of Bullous Pemphigoid

(IN BRIEF) Sanofi’s Dupixent has been granted FDA priority review for the treatment of bullous pemphigoid (BP), a chronic skin disease. If approved, Dupixent would be the first targeted medicine for BP in the U.S., with the FDA’s decision expected … Read the full press release