News AZ immunotherapy gets FDA boost in early lung cancer Imfinzi given Breakthrough Therapy designation from the FDA.
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 Third Rock in $2bn drug-hunting pact with China's Funnel New Chinese biotech Funnel has signed a $2bn-plus partnership with Third Rock Ventures, focused on using its AI platform to discover novel biologics.
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