We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Sandoz’s application to produce a biosimilar of Amgen’s bone marrow drug Neulasta has been rebuffed by the agency, according to Sandoz’s parent company, Novartis. Read More
The FDA is pressing a GlaxoSmithKline subsidiary to make a hard choice about operations at a U.K. plant: either decontaminate the whole facility to address repeated problems with penicillin contamination or else restrict production to penicillin. Read More
An FDA advisory committee unanimously backed FDA approval of Valeant’s Siliq to treat plaque psoriasis, but was split on the risk management of the candidate due to reported suicides. Read More
The FDA wants to see both efficacy and effectiveness data in future postmarket filings to better conform to International Conference on Harmonization standards. Read More