United States Food and Drug Administration
Galderma’s Nemluvio Receives FDA Approval for Prurigo Nodularis Treatment
Nemluvio, Galderma, FDA Approval, Prurigo Nodularis, IL-31 Inhibitor, Chronic Skin Condition, Itch Treatment
Aldeyra’s Reproxalap Demonstrates Efficacy in Reducing Eye Discomfort in New Phase 3 Study
Aldeyra Therapeutics, Reproxalap, Phase 3 Study, Eye Discomfort, Dry Eye Disease, FDA Rejection
Ascendis Pharma Secures FDA Approval for YORVIPATH, a Novel Hormone Replacement Therapy for Hypoparathyroidism
Ascendis Pharma, YORVIPATH, FDA approval, hormone replacement therapy, hypoparathyroidism, TransCon PTH, palopegteriparatide
FDA Approves ARS’s Epinephrine Nasal Spray for Emergency Allergic Reactions
FDA approval, epinephrine nasal spray, ARS Pharmaceuticals, anaphylaxis treatment, needle-free alternative, EpiPen
Alfasigma’s PBC Treatment Ocaliva to Face FDA Advisory Committee in September
Alfasigma, Ocaliva, PBC, FDA advisory committee, primary biliary cholangitis, liver disease treatment
Novartis’ Fabhalta Clinches Another FDA Win, This Time in IgA Nephropathy
Novartis, Fabhalta, FDA approval, IgA nephropathy, proteinuria reduction, complement inhibitor, kidney disease
FDA Criticizes Bristol Myers Squibb for Misleading Efficacy Claims on Krazati Website
Bristol Myers Squibb, FDA, Krazati, misleading efficacy claims, non-small-cell lung cancer, NSCLC, KRAS G12C-mutated, cancer treatment
Apellis and Sobi Achieve Significant Breakthrough in Phase 3 Trial for Rare Kidney Disease Treatment
Apellis Pharmaceuticals, Sobi, pegcetacoplan, Phase 3 VALIANT study, C3 glomerulopathy, primary immune complex membranoproliferative glomerulonephritis, proteinuria reduction, kidney disease treatment, FDA approval, European Medicines Agency
Madrigal’s MASH Drug Rezdiffra Surpasses Q2 Sales Estimates
Madrigal Pharmaceuticals, Rezdiffra, MASH drug, Q2 earnings, sales estimates, FDA approval, commercial launch, NASH treatment
FDA Approves Servier’s Brain Cancer Drug, Triggering $1 Billion Payout for Agios
FDA approval, Servier, brain cancer drug, Voranigo, Agios Pharmaceuticals, IDH1 and IDH2 mutations, blood-brain barrier, cancer metabolism, royalty payments