Amid a parade of regulatory endorsements in Europe, Apellis Pharmaceuticals’ ophthalmology prospect pegcetacoplan has been ...
Upon authorization by the European Commission, the Omicron KP.2-adapted COVID-19 vaccine will be available for individuals 6 months of age and ...
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NVO Gets Positive CHMP Opinion for Wegovy's Label Update in EUNovo Nordisk A/S NVO announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) ...
EMA’s human medicines committee elects Bruno Sepodes as new chair: Amsterdam, The Netherlands Friday, September 20, 2024, ...
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 ...
Pfizer and BioNTech’s Omicron KP.2-adapted COVID-19 vaccine has received a positive recommendation from the European ...
Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion ...
Update on FDA's Applied Therapeutics, Inc. decision to remove advisory panel for govorestat review in treating galactosemia.
BAGSVAERD, Denmark I 19, 2024 I Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human ...
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 greater proportion ...
Upon authorization by the European Commission, the Omicron KP.2-adapted COVID-19 vaccine will be available for individuals 6 months of age and older Data demonstrate that the Omicron KP.2-adapted ...
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