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A bioethicists opinion piece in The Hill says FDA needs to expand its reliance on real-world clinical data to monitor the safety a...[ Price : $8.95]
FDA issues a complete response letter to Unicycive Therapeutics for its hyperphosphatemia drug oxylanthanum carbonate that cites i...[ Price : $8.95]
FDA gives accelerated approval to Dizals lung cancer drug Zegfrovy, along with a companion diagnostic device.[ Price : $8.95]
FDA warns Staska Pharmaceuticals, a Bennett, NE, outsourcing facility, about its multiple failures to meet requirements for such f...[ Price : $8.95]
FDA issues an Early Alert for an Abiomed Automated Impella Controller issue that has resulted in three deaths.[ Price : $8.95]
After delaying a review action last month, FDA now approves a KalVista Pharmaceuticals NDA for Ekterly (sebetralstat) for treating...[ Price : $8.95]
FDA accepts for priority review a Denali Therapeutics BLA for tividenofusp alfa for treating Hunter syndrome.[ Price : $8.95]
A ProPublica investigative report says FDA inspectors continue to have issues arising from the dismissal of many of their support ...