FDA approves VivaSight (ETView Medical) for use in Lung Surgery
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Amicus Therapeutics announced that the European Medicines Agency validated the Marketing Authorization Applications (MAA) for AT GAA (cipaglucosidase alfa + miglustat), the Company’s investigational two-component therapy for the treatment of Pompe disease.
Bristol Myers Squibb announced that the FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for Reblozyl (luspatercept-aamt), a first-in-class erythroid maturation agent, for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia.
BeiGene, Ltd. and EUSA Pharma (UK), Ltd. announced that the China National Medical Products Administration (NMPA) has approved Sylvant (siltuximab for injection) for the treatment of adult patients with multicentric Castleman disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpes virus-8 (HHV-8) negative, also known as idiopathic MCD (iMCD).