Login to Your Account


With an FDA advisory committee voting 14-1 Thursday to recommend licensure of Hospira Inc.'s epoetin biosimilar, the U.S. is one step closer to catching up with other markets that are nearly a decade ahead on the biosimilar path.

Following an initial rejection over manufacturing issues, FDA approval for the rheumatoid arthritis (RA) therapy sarilumab arrived late Monday.

A surprise FDA approval allowing Vertex Pharmaceuticals Inc. to expand the label for its cystic fibrosis (CF) therapy, Kalydeco (ivacaftor), to include an additional 3 percent of the CF population with certain rare residual function mutations boosted forecast sales for the therapy and lent credence to the potential power of in vitro assays to sway the agency in certain cases.

More U.S. Headlines

Cast Your Vote

Should there be restrictions on the use of gene-editing technology?: