Allergan files a citizen petition asking FDA to refuse to receive and approve any ANDA that references the companys NDA for Viberzi (eluxadoline) tabl...
FDA says it used new regulatory tools to approve a Novartis NDA for Piqray (alpelisib) tablets, indicated for treating postmenopausal women and men wi...
FDA approves an AveXis BLA for Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy approved to treat children less than two years of age...
Edwards Lifesciences recalls its EV1000A, EV1000NI, EV1000CS EV100 Clinical Platforms due to the potential for fluids to leak into the AC power outlet...
Federal Register notice: FDA determines that the regulatory review period for Edwards Lifesciences Edwards Intuity Elite Aortic Valve is 1,508 days.
Federal Register notice: FDA makes available a final guidance entitled Section 503A Bulks List Final Rule Questions and Answers.
FDA clears a CD Diagnostics de novo marketing request for the Synovasure Lateral Flow Test Kit to serve as an aid for detecting periprosthetic joint i...
Researchers call for a more standardized approach to research real-world evidence and its best uses.