Approved
Gilead’s $4.3B Acquisition of CymaBay Yields FDA Approval for Autoimmune Liver Disease Treatment
Gilead Sciences, CymaBay, FDA Approval, Autoimmune Liver Disease, Seladelpar, Primary Biliary Cholangitis
AstraZeneca Secures Landmark EU Approval for Imfinzi-Lynparza Combo in Endometrial Cancer Treatment
AstraZeneca, Imfinzi, Lynparza, endometrial cancer, EU approval, combination therapy, immunotherapy, PARP inhibitor, mismatch repair proficient, mismatch repair deficient
Galderma’s IL-31 Blocker Nemluvio Gains FDA Approval for Prurigo Nodularis
Galderma, Nemluvio, IL-31 blocker, FDA approval, prurigo nodularis, therapeutic dermatology
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