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A federal appeals court upheld a lower court ruling that Phigenix lacked evidence to prove a patent infringement case against Genentech for the breast cancer drug Kadcyla (ado-trastuzumab emtansine). Read More
Calls for the nomination of acting FDA Commissioner Ned Sharpless to fill the permanent leadership role at the agency continue to grow as the cutoff date for his acting status approaches. Read More
The drug was approved in March for use in combination with carboplatin and etoposide as a first-line treatment for adult patients with extensive-stage small cell lung cancer. Read More
Mallinckrodt has agreed to settle allegations that its subsidiary Questcor Pharmaceuticals bribed physicians to over-prescribe its multiple sclerosis drug H.P. Acthar Gel (repository corticotropin). Read More
Sponsors of drugs to treat partial onset seizures (POS) in pediatric patients should extend their trials to children as young as two, according to a final guidance the FDA released on Thursday. Read More