[ 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 ...[ 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...