FDA gives accelerated approval to Dizals lung cancer drug Zegfrovy, along with a companion diagnostic device.
FDA warns Staska Pharmaceuticals, a Bennett, NE, outsourcing facility, about its multiple failures to meet requirements for such facilities.
FDA issues an Early Alert for an Abiomed Automated Impella Controller issue that has resulted in three deaths.
After delaying a review action last month, FDA now approves a KalVista Pharmaceuticals NDA for Ekterly (sebetralstat) for treating acute attacks of he...
FDA accepts for priority review a Denali Therapeutics BLA for tividenofusp alfa for treating Hunter syndrome.
A ProPublica investigative report says FDA inspectors continue to have issues arising from the dismissal of many of their support staff.
FDA accepts and will give priority review to a Merck sBLA for a Winrevair labeling update based on ZENITH trial results.
Former FDA commissioner Scott Gottlieb raises significant questions about the current administrations handling of vaccines and vaccine innovation in w...
