News FDA launches pilot to streamline digital health regulation Pre-Cert for Software Pilot Program aims to develop framework to speed up access to new digital health tools.
News Victory for Puma as FDA approves breast cancer drug Neratinib can be used to reduce risk of disease returning.
News Spark files revolutionary gene therapy with FDA Luxturna granted six-month priority review by FDA.
News FDA rejects Amgen/UCB osteoporosis drug The FDA has rejected Amgen and UCB’s Evenity (romosozumab) osteoporosis drug after a late-stage trial unexpectedly highlighted a potential cardiac safety risk.
News J&J's psoriasis drug faces crowded market after US approval J&J taking on next gen drugs from Novartis, Eli Lilly, and Valeant.
News GBL joins CVC in €10.7bn takeover bid for Recordati A consortium of investors has made a €10.7bn offer to take Italian pharma Recordati private, but some analysts are sceptical the deal will go through.
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