CHMP
CHMP recommends seven label expansions and one new approval, rejects Lilly Alzheimer’s drug
CHMP, Labels (device), expansions, Approved
J&J’s Subcutaneous Rybrevant Receives CHMP Backing for Lung Cancer Treatment Despite Recent FDA Rejection
Rybrevant, amivantamab, Johnson & Johnson, CHMP, FDA, subcutaneous formulation, non-small cell lung cancer, EGFR mutations
EMA Reverses Decision, Recommends Approval of Lecanemab (Leqembi) for Early Alzheimer’s Disease in Specific Patient Group
Lecanemab, Leqembi, Alzheimer’s disease, EMA, CHMP, early Alzheimer’s disease, ApoE ε4, amyloid-beta monoclonal antibody
European Commission’s Reconsideration of Translarna’s Marketing Authorization: A Critical Turning Point for Duchenne Muscular Dystrophy Treatment
Translarna, Duchenne muscular dystrophy, European Commission, EMA, CHMP, conditional marketing authorization, drug approval, regulatory decisions
Novo Nordisk’s Alhemo Nears EU Approval: A Breakthrough in Haemophilia Treatment
Novo Nordisk, Alhemo, Haemophilia A and B, Inhibitors, European Medicines Agency (EMA), CHMP positive opinion, Subcutaneous prophylactic treatment, Concizumab
EU Approves Novo Nordisk’s Groundbreaking Once-Weekly Basal Insulin Icodec for Adults with Diabetes
Novo Nordisk, Once-Weekly Insulin Shot, Awiqli, Insulin Icodec, European Medicines Agency (EMA), CHMP Positive Opinion, Type 1 & Type 2 Diabetes Treatment
Brukinsa Broadens Horizons: FDA Clears Follicular Lymphoma Combination Therapy
Brukinsa, Follicular lymphoma, FDA approval, BTK inhibitor, BTK inhibitor, Broadest label, Relapsed or refractory follicular lymphoma, ROSEWOOD Phase II study, CHMP positive opinion, Obinutuzumab combination therapy, Accelerated approval, Relapsed or refractory follicular lymphoma, Relapsed or refractory marginal zone lymphoma, Chronic lymphoma, CHMP recommendation, Phase II ROSEWOOD trial, Overall response rate (OR