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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 ...[ Price : $8.95]
In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Mo...[ Price : $8.95]
A new FDA report examines the demographic representation of clinical trials supporting the approval of 50 novel drug therapies las...[ Price : $8.95]
FDA removes risk evaluation and mitigation strategies requirements for all currently approved CAR T cell therapies, saying the pro...[ Price : $8.95]
UCB reports positive data from a Phase 3 clinical trial evaluating fenfluramine as an adjunctive treatment for rare epileptic ence...