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
FDA Delays Dupixent Decision for COPD by Three Months, EMA Recommends Approval
FDA, Dupixent, COPD, EMA, Regeneron, Sanofi, Priority Review, PDUFA, Boreas, Notus, Phase III Trials
Novartis’ Fabhalta (Iptacopan) Receives FDA Priority Review for IgA Nephropathy (IgAN) Treatment
Novartis, Fabhalta, Iptacopan, IgA Nephropathy (IgAN), FDA Priority Review, Phase 3 Data
Basilea Secures FDA Approval for Zevtera to Treat Three Types of Bacterial Infections
Basilea Pharmaceutica, Zevtera (ceftobiprole), FDA approval, Acute bacterial skin and skin structure infections (ABSSSI), Staphylococcus aureus bacteremia (SAB), Community-acquired bacterial pneumonia (CABP), Qualified Infectious Disease Product (QIDP) status, Priority Review/ Fast Track/ and QIDP designations, Ten years of exclusivity in the US
FDA Awaits Final Decision on Madrigal’s Resmetirom for NASH Treatment with Priority Review and NDA Acceptance Set for March 14, 2024
Nonalcoholic Steatohepatitis, resmetirom, United States Food and Drug Administration, New Drug Application, Priority Review, Fibrosis, Liver, Liver, Madrigal’s, March 14, 2024