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FDA clears a NeuroOne Medical Technologies 510(k) to market its thin film cortical electrode technology for temporary (less than 3...[ Price : $8.95]
Immunomedics resubmits its BLA seeking accelerated approval for sacituzumab govitecan, indicated for treating certain patients wit...[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Ultragenyxs Crysvita.[ Price : $8.95]
FDA releases a final guidance entitled Adaptive Designs for Clinical Trials of Drugs and Biologics.[ Price : $8.95]
FDA says that most recent, interim post-approval study results for the Impella RP System continue to show a favorable survival ra...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension on a requirement for submitting certain pediatr...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of 21 ANDAs from multiple applicants after they notified the agency that the drug ...[ Price : $8.95]
FDA orders Gynecology, Reproductive Endocrinology and Fertility Institute to immediately stop manufacturing cell/tissue products a...