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