FDA extends by three months its review of a Novartis supplemental BLA for ofatumumab (OMB 157), a self-administered, targeted B-cell therapy for patie...
Federal Register notice: FDA posts additional draft and revised draft product-specific guidances on bioequivalence study designs to support ANDAs.
FDA makes the Covid MyStudies app available for investigators to use to obtain informed consent electronically.
FDA issues an immediately effective guidance on conducting clinical trials of medical products during the current public health emergency.
FDA clears a Welldoc 510(k) to add a new feature to its digital health product BlueStar Rx which supports individuals using long-acting insulin.
The Motley Fool says FDAs drug competition initiative to promote generic drugs is good for consumers but can hurt some investors.
FDA grants Noctrix Health a Breakthrough DevicR-CASEe Designation for its wearable NTX100 neuromodulation therapy designed for treating adults with re...
Two stakeholders comment on an FDA draft guidance on evaluating the safety of new drugs for improving glycemic control.