Approved
Novartis Fails to Block MSN’s Entresto Generic Launch
Novartis, Entresto, MSN Pharmaceuticals, generic drugs, patent infringement, FDA approval
FDA Approves Sandoz and Ascendis Pharma’s Treatments for nAMD and Hypoparathyroidism
FDA approval, Sandoz, Ascendis Pharma, nAMD, hypoparathyroidism, Yorvipath, TransCon PTH
Galderma’s Nemluvio Receives FDA Approval for Prurigo Nodularis Treatment
Nemluvio, Galderma, FDA Approval, Prurigo Nodularis, IL-31 Inhibitor, Chronic Skin Condition, Itch Treatment
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
Novartis’ Fabhalta Clinches Another FDA Win, This Time in IgA Nephropathy
Novartis, Fabhalta, FDA approval, IgA nephropathy, proteinuria reduction, complement inhibitor, kidney disease
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
FDA Approves Voranigo, the First Targeted Therapy for Grade 2 IDH-Mutant Glioma
Voranigo, FDA approval, targeted therapy, Grade 2 IDH-mutant glioma, brain tumor, Servier Pharmaceuticals, IDH1/IDH2 inhibitor