Amid a parade of regulatory endorsements in Europe, Apellis Pharmaceuticals’ ophthalmology prospect pegcetacoplan has been ...

Novo Nordisk receives a positive opinion from the CHMP for a label update of Wegovy to reflect reduced heart failure symptoms ...

EMA’s human medicines committee elects Bruno Sepodes as new chair: Amsterdam, The Netherlands Friday, September 20, 2024, ...

Upon authorization by the European Commission, the Omicron KP.2-adapted COVID-19 vaccine will be available for individuals 6 months of age and ...

Pfizer and BioNTech’s Omicron KP.2-adapted COVID-19 vaccine has received a positive recommendation from the European ...

OPUVIZ, a biosimilar referencing Eylea1 (aflibercept), is Samsung Bioepis and Biogen's second ophthalmology biosimilar to be recommended for marketing authorization by the European Medicines Agency IN ...

Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old Recommendation based on a phase 3 study showing a significantly ...

Update on FDA's Applied Therapeutics, Inc. decision to remove advisory panel for govorestat review in treating galactosemia.

It also means that most regulatory watchers may not be looking at the appropriate endpoint for calculating and comparing relative cycle times. In most cases, the EC agrees with the CHMP's ...