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Nobel Prize awarded for research that paved the way for Covid-19 mRNA vaccines

The Nobel Prize in Physiology and Medicine has been awarded to two scientists whose research allowed for the development of …

Basilea pre-emptively seeks US partner for ceftobiprole as FDA accepts NDA

The US Food and Drug Administration (FDA) has accepted Basilea Pharmaceutica’s new drug application (NDA) for ceftobiprole, with the agency …

FDA approves Empaveli injector for PNH patients

The US Food and Drug Administration (FDA) has approved Apellis Pharmaceuticals’  Empaveli injector (Enfuse) for the subcutaneous delivery of Empaveli …

Biogen edges out competition to win first FDA approval for Actemra biosimilar

Biogen has entered the crowded arthritis market in the US following approval of its biosimilar Tofidence (tocilizumab-bavi) by the US …

FDA lifts partial hold on Phase III plans for rare ataxia drug

Quince Therapeutics has announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold placed on …