Priority Review
FDA Grants Dupixent (Dupilumab) Eighth Approval: Now Cleared for Bullous Pemphigoid
Dupixent; Dupilumab; Sanofi; Regeneron; bullous pemphigoid; FDA approval; type 2 inflammation; autoimmune disease; priority review; orphan drug
Bavarian Nordic Sells FDA Priority Review Voucher for $160M Amid Rising Industry Prices and Program Scrutiny
Bavarian Nordic; Priority Review Voucher; FDA; voucher sale; $160 million; chikungunya vaccine; VIMKUNYA; NIH; antitrust review; biotech finance
FDA Launches New Priority Review Voucher Program Aligned with National Priorities
FDA; priority review voucher; CNPV; biopharma; drug approval; national priorities; accelerated review; unmet public health needs
Otsuka’s Phase 3 IgAN Win with Sibeprenlimab Shakes Vera’s Stock
Otsuka; sibeprenlimab; IgA nephropathy; phase 3 trial; proteinuria reduction; Vera Therapeutics; stock drop; kidney disease; UPCR; FDA Priority Review
FDA Approves Imfinzi for Limited-Stage Small Cell Lung Cancer, Marking First Systemic Immunotherapy for LS-SCLC
Imfinzi (durvalumab), Limited-stage small cell lung cancer (LS-SCLC), FDA approval, Systemic immunotherapy, ADRIATIC Phase III trial, Breakthrough Therapy Designation, Priority Review
PTC Therapeutics Sells Priority Review Voucher for $150M Following Phase 2 ALS Trial Failure
PTC Therapeutics, ALS, Phase 2 trial failure, priority review voucher, $150M sale
Acadia Generates $100 Million from Pediatric Disease Priority Review Voucher Sale
Acadia Pharmaceuticals, Pediatric Disease Priority Review Voucher, Pharmaceutical Industry, Financial Transactions
FDA Decision on Vertex’s Non-Opioid Analgesic Suzetrigine Due Early Next Year
FDA, Vertex, Suzetrigine, Non-Opioid Analgesic, Acute Pain, PDUFA, Priority Review
Congress Must Reauthorize FDA Program for Pediatric Rare Diseases to Save Lives
Pediatric Rare Diseases, FDA Program, Reauthorization, Creating Hope Act, Priority Review Voucher Program
Jazz Pharmaceuticals Presents Groundbreaking HER2 Biliary Tract Cancer Data Ahead of FDA Decision
Jazz Pharmaceuticals, HER2, Biliary Tract Cancer, FDA Decision, Zanidatamab, Priority Review