viernes, 1 de diciembre de 2017

FDA approvals Nov. 30 and Dec. 1, 2017


U.S. Food and Drug Administration Header

FDA approvals November 30 - December 1, 2017


  • FDA approved Ogivri (trastuzumab-dkst, Mylan) as a biosimilar to Herceptin (trastuzumab, Genentech, Inc.) for the treatment of patients with HER2-overexpressing breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). More Information.  December 1, 2017
  • FDA granted marketing approval to the FoundationOne CDx (F1CDx, Foundation Medicine, Inc.), a next generation sequencing (NGS) based in vitro diagnostic (IVD) to detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. More Information.  November 30, 2017

Other Hematology/Oncology (Cancer) Approvals & Safety Notifications

No hay comentarios:

Publicar un comentario