Committee for Medicinal Products for human use– tag –
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Daiichi Sankyo/AstraZeneca’s Datroway Receives US FDA Approval for First-Line Metastatic TNBC, EMA CHMP Gives Positive Opinion
Chemistry Today USA Overview Datroway (datopotamab deruxtecan), the TROP2-directed DXd ADC co-developed by Daiichi Sankyo and AstraZeneca, has received US FDA approval as a first-line treatment for unresectable or metastatic triple-negat... -
EMA’s CHMP Endorses Marketing Authorization Expansion for Rhythm Pharmaceuticals’ IMCIVREE (setmelanotide) for Childhood Obesity in Rare Genetic Disorders (Ages 2+)
Bio-Research.AI Europe Overview Rhythm Pharmaceuticals announced that the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the marketing authorization expansion for IMCIVREE (setmelanoti... -
Breakthrough: EU Approves Oral BTK Inhibitor Tolebrutinib as First Disability-Targeting Therapy for Nonrelapsing SPMS
NeurologyLive Europe Overview The European Commission has approved Sanofi's oral, brain-penetrant Bruton's tyrosine kinase (BTK) inhibitor, tolebrutinib (Cenrifki), for nonrelapsing secondary progressive multiple sclerosis (SPMS). This a... -
EMA Panel Backs Incyte’s Opzelura: Topical JAK Inhibitor Promises Rapid Relief for Moderate Atopic Dermatitis
Medical Update Online Europe Overview The European Medicines Agency's (EMA) CHMP has issued a positive opinion for Incyte's Opzelura (ruxolitinib) cream, recommending its approval for adult patients with moderate atopic dermatitis unresp... -
EMA Recommends Approval for New Hypercholesterolemia Drug Evlarco (Obicetrapib / Ezetimibe): A Combination of CETP Inhibitor and Cholesterol Absorption Inhibitor
EMA EU Overview On July 23, 2026, the EMA's CHMP adopted a positive opinion recommending marketing authorization for Evlarco (obicetrapib / ezetimibe). This oral medication is for the treatment of primary hypercholesterolemia or mixed dy... -
Daiichi Sankyo & AstraZeneca’s Enhertu Plus Pertuzumab Recommended for EU Approval as 1st-Line Treatment for HER2-Positive Metastatic Breast Cancer, Achieves 44% Risk Reduction in Phase III
Daiichi Sankyo Press Release Japan Overview The EMA's CHMP has recommended Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for approval as a first-line treatment for HER2-positive metastatic breast cancer in the EU. This ... -
EMA CHMP Recommends 12 Medicines for Approval, Including 3 New Hypercholesterolemia Drugs and Therapies for Cholestatic Pruritus and Cerebral Adrenoleukodystrophy
EMA EU Overview The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for twelve medicines at its July 2026 meeting. This includes three new medicines for hypercholesterolemia or mixed dyslipidemia: Ly... -
EMA Confirms Acceptance of Marketing Authorization Application for Novel Early Alzheimer’s Drug Candidate
PharmaNews Europe Europe Overview The European Medicines Agency (EMA) has confirmed acceptance of a Marketing Authorization Application (MAA) for a novel drug candidate targeting early Alzheimer's disease. The application includes pivota... -
Daiichi Sankyo and AstraZeneca’s Gastric Cancer ADC Receives Positive EMA CHMP Opinion for Approval
European Medicines Agency (EMA) Europe Overview The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending approval for an antibody-drug conjugate (ADC) develo...
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