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marketing authorization

European Commission Approves Pfizer’s VELSIPITY® for Patients with Moderately to Severely Active Ulcerative Colitis

Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for VELSIPITY (etrasimod) in the European Union to treat patients 16 years...

MCRA Assists Attune Medical on FDA De Novo Marketing Authorization for ensoETM™ Esophageal Thermal Regulating Device

MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations,...

Novavax’s Nuvaxovid™ Receives Positive CHMP Opinion for Full Marketing Authorization for the Prevention of COVID in the EU

Novavax, Inc, a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, announced that Nuvaxovid (NVX-CoV2373) has been recommended for full Marketing Authorization...

Mirum Submits for European Approval of LIVMARLI in Progressive Familial Intrahepatic Cholestasis

Mirum Pharmaceuticals, Inc. announced submission to the European Medicines Agency (EMA) of a variation application to the Marketing Authorization for LIVMARLI (maralixibat) oral solution,...

Novavax Nuvaxovid COVID-19 Vaccine Recommended by CHMP

Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine has been...
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