European Commission Grants Approval for KALYDECO® to Treat Cystic Fibrosis in Infants as Young as 1 Month Old, Announces Vertex

Vertex Pharmaceuticals (Nasdaq: VRTX) has received approval from the European Commission for the expansion of KALYDECO® (ivacaftor) labeling. This approval allows for the treatment of infants as young as 1…

Read MoreEuropean Commission Grants Approval for KALYDECO® to Treat Cystic Fibrosis in Infants as Young as 1 Month Old, Announces Vertex

Amgen Prepares to Present Marketing Authorization Application for Teprotumumab to the European Medicines Agency

Amgen (NASDAQ:AMGN) has announced its forthcoming submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for teprotumumab. Teprotumumab, a fully human monoclonal antibody and targeted inhibitor…

Read MoreAmgen Prepares to Present Marketing Authorization Application for Teprotumumab to the European Medicines Agency

CHMP Recommends Approval of Bristol Myers Squibb’s Opdivo® for First-Line Treatment of Unresectable or Metastatic Urothelial Carcinoma

Bristol Myers Squibb (NYSE: BMY) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Opdivo® (nivolumab)…

Read MoreCHMP Recommends Approval of Bristol Myers Squibb’s Opdivo® for First-Line Treatment of Unresectable or Metastatic Urothelial Carcinoma