Approved
Sandoz Challenges Amgen in Antitrust Lawsuit to Launch Enbrel Biosimilar in the U.S.
Sandoz, Amgen, Enbrel, Erelzi, antitrust, biosimilar, etanercept, patent thicket, U.S. market, rheumatoid arthritis, competition, biologics, FDA approval.
Annexon Advances Guillain-Barré Syndrome Awareness and Introduces Groundbreaking Targeted Therapy
Guillain-Barré Syndrome (GBS) , Annexon , Tanruprubart (ANX005) , Targeted therapy , GBS education campaign , Move GBS Forward™ , Phase 3 trial results , FDA approval
: BMS’ Opdivo plus Yervoy snags FDA nod as first-line treatment for certain colorectal cancer patients
United States Food and Drug Administration, Approved, Burning Mouth Syndrome, Colorectal Carcinoma, Yervoy, first-line, Combined
Novavaxs held-up approval package may signal warning for Covid vaccine makers
Vaccines, Approved, COVID19 (disease), United States Food and Drug Administration, Market, Novavax ‘s, Maker (occupation), Deferred
FDA official said to step in and pause review of Novavax’s COVID-19 vaccine
United States Food and Drug Administration, COVID19 (disease), Vaccines, Novavax ‘s, Review [Publication Type], Novavax, Approved
FDA okays Novartis’ second IgA nephropathy therapy Vanrafia
Vanrafia, United States Food and Drug Administration, Approved, Novartis, IGA Glomerulonephritis, Proteinuria
CHMP recommends seven label expansions and one new approval, rejects Lilly Alzheimer’s drug
CHMP, Labels (device), expansions, Approved
Soleno breaks through with FDA nod for Prader-Willi syndrome treatment Vykat XR
FDA approval, Vykat XR, Prader-Willi syndrome, hyperphagia, Soleno Therapeutics, diazoxide choline
FDA clears Exelixis’ TKI for neuroendocrine tumours
CABOMETYX, cabozantinib, neuroendocrine tumors, FDA approval, Exelixis, tyrosine kinase inhibitor
Wave Life Sciences’ WVE-N531 Shows Promise in Duchenne Muscular Dystrophy Treatment
Duchenne muscular dystrophy (DMD), WVE-N531, exon 53 skipping, Phase II trial, dystrophin expression, muscle health improvement, FDA approval