Pink SheetAfter approving seven novel agents in June, the US FDA may be able to relax a little in July. The coming month features a handful of novel agents, new formulations, and an OTC product among fewer than
Generics BulletinStrides Pharma Science has been granted a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use, recommending granting a pan-European marketing authorizat
Pink SheetVidPrevtyn Beta, from Sanofi and GSK , has become the first COVID-19 vaccine to win EU marketing approval based on immunobridging trials. Well-justified and appropriately designed immunobridging st
Pink SheetThe US FDA Center for Biologics Evaluation and Research approved its third novel biologic of 2022 on 3 June, clearing GlaxoSmithKline plc ’s measles, mumps and rubella vaccine Priorix late in the day