Federal Register notice: FDA debars George Kuiper for a period of five years from importing or offering for import any drug into the U.S. due to felon...
FDA grants DexCom a breakthrough device designation for its Dexcom real-time continuous glucose monitoring system for use in the hospital setting.
Sens. Collins and Capito ask the Centers for Medicare and Medicaid Services to ensure that its national coverage decision on Aduhelm does not restrict...
FDA extends by three months its review of a TG Therapeutics BLA and supplemental NDA for ublituximab in combination with Ukoniq (umbralisib), indicate...
Median Technologies files a 513(g) submission seeking FDA guidance on the best path to market for its iBiopsy Lung Cancer Screening Artificial Intelli...
FDA clears a Circa Scientific 510(k) for its S-CATH M Esophageal Temperature Probe which can be visualized on 3D cardiac mapping systems.
Civica says it will develop and manufacture three insulin biosimilars to be sold at a lower price than current products.
Federal Register notice: FDA permanently debars Eduardo Navarro from providing services related to an approved or pending drug product application.