Can X4 Pharmaceuticals and Norgine unlock EU access to the first targeted WHIM therapy?
EMA backs mavorixafor for WHIM syndrome. Explore what EU approval could mean for access, evidence standards, and rare immunology treatment.
Pharma & Biotech
Medical Devices & Diagnostics
CHMP backs Vueway pediatric expansion, signaling a cautious but meaningful shift in neonatal MRI contrast use
Bracco Imaging S.p.A. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion supporting the use of Vueway gadopiclenol in pediatric patients from birth. The recommendation extends an existing European Union authorization and places the macrocyclic gadolinium-based contrast agent into one of the
Pharma & Biotech
Can Novo Nordisk’s semaglutide 7.2 mg set a new standard in obesity treatment?
Novo Nordisk's semaglutide 7.2 mg achieves 20.7% weight loss. Find out what this EU regulatory step means for obesity treatment and patient outcomes in 2026.
Pharma & Biotech
Merck’s WINREVAIR clears major EU hurdle with CHMP backing for WHO FC IV patients
Merck has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending an expanded indication for WINREVAIR (sotatercept) in combination with other therapies for the treatment of pulmonary arterial hypertension (PAH) in adults across WHO Functional Classes II, III, and IV. The update follows pivotal
Pharma & Biotech
Can Gotenfia finally unlock biosimilar competition for Simponi in Europe?
STADA Arzneimittel AG and Bio-Thera Solutions have secured a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Gotenfia, a proposed biosimilar to the tumor necrosis factor alpha inhibitor golimumab. The product references Simponi, an originator drug widely prescribed for multiple autoimmune conditions. If approved, Gotenfia would be marketed
Pharma & Biotech
Will Aspaveli reshape rare kidney disease treatment in Europe? CHMP greenlight sets regulatory milestone
Swedish Orphan Biovitrum AB has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Aspaveli, the pegcetacoplan-based therapy developed in partnership with Apellis Pharmaceuticals Inc., for the treatment of C3 glomerulopathy and primary immune-complex membranoproliferative glomerulonephritis. The recommendation covers use in patients aged 12 years and older