EuropaWire8h
Pfizer and BioNTech’s Omicron KP.2-Adapted COVID-19 Vaccine Receives Positive EU Opinion, Awaiting Approval
Pfizer and BioNTech’s Omicron KP.2-adapted COVID-19 vaccine has received a positive recommendation from the European ...
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Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Aflibercept Biosimilar, OPUVIZ™
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 ...
Santé log22h
Ipsen’s Iqirvo® (elafibranor) approved in the European Union as first new treatment for primary biliary cholangitis in nearly a decade
This new European approval reinforces Ipsen’s commitment to advancing medical innovations to treat people living with rare cholestatic liver diseases ...
NVO Gets Positive CHMP Opinion for Wegovy's Label Update in EU
Novo Nordisk receives a positive opinion from the CHMP for a label update of Wegovy to reflect reduced heart failure symptoms ...
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron KP.2-adapted COVID-19 Vaccine in the European Union
Upon authorization by the European Commission, the Omicron KP.2-adapted COVID-19 vaccine will be available for individuals 6 months of age and ...
FiercePharma1d
Europe's CHMP turns down Apellis' pegcetacoplan appeal, endorses new drugs from Pfizer, ImmunoGen and Henlius
Amid a parade of regulatory endorsements in Europe, Apellis Pharmaceuticals’ ophthalmology prospect pegcetacoplan has been ...
Dupixent® (dupilumab) Recommended for EU Approval by the CHMP to Treat Eosinophilic Esophagitis (EoE) in Children as Young as 1 Year Old
Recommendation based on a Phase 3 trial showing a significantly greater proportion of children on Dupixent achieved histological remission ...
Armed robbery in Revesby1d
Pfizer/BioNTech Get CHMP Nod for Omicron KP.2 EU Vaccine
Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the Committee for Medicinal Products for Human Use ...
European Drug Agency Supports Novo Nordisk's Blockbuster Weight-Loss Drug Wegovy For Obesity-Related Heart Failure
Novo Nordisk's Wegovy label update receives a positive opinion from the EMA's CHMP, highlighting improvements in heart ...
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Marinus Pharmaceuticals to Highlight Clinical Progress and Commercial Launch Preparedness for ZTALMY® in TSC at Investor and Analyst Day
Marinus Pharmaceuticals, Inc. , a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today is hosting an Investor and Analyst Day and will ...