FDA clears a NeuroOne Medical Technologies 510(k) to market its thin film cortical electrode technology for temporary (less than 30 days) recording, m...
Immunomedics resubmits its BLA seeking accelerated approval for sacituzumab govitecan, indicated for treating certain patients with metastatic triple-...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Ultragenyxs Crysvita.
FDA releases a final guidance entitled Adaptive Designs for Clinical Trials of Drugs and Biologics.
FDA says that most recent, interim post-approval study results for the Impella RP System continue to show a favorable survival rate compared with pre...
Federal Register notice: FDA seeks comments on an information collection extension on a requirement for submitting certain pediatric subpopulation dat...
Federal Register notice: FDA withdraws approval of 21 ANDAs from multiple applicants after they notified the agency that the drug products were no lon...
FDA orders Gynecology, Reproductive Endocrinology and Fertility Institute to immediately stop manufacturing cell/tissue products after an October insp...