CDER issues a MAPP on procedures for clinical consultative review of drugs regulated in the Office of New Drugs.
FDA clears a W. L. Gore 510(k) for its Gore Synecor Preperitoneal Biomaterial hernia repair device, which offers treatment options for the full range ...
Former FDA associate commissioner Peter Pitts supports the agency relaxing its rules on sharing of truthful and non-misleading information on off-labe...
Novartis says its CTL019 drug for treating diffuse large B-cell lymphoma had promising results in a Phase 2 trial.
The House Energy and Commerce Committee votes 54 to 0 to advance legislation to reauthorize FDA user fee programs, sending the measure to a floor vote...
FDA clears a W. L. Gore 510(k) for its Gore Synecor Preperitoneal Biomaterial hernia repair device, which offers treatment options for the full range ...
FDA approves a Hologic PMA supplement for the Genius 3D Mammography exam and its use being superior to standard 2D mammography for routine breast canc...
Federal Register notice: FDA announces a 7/13 Oncologic Drugs Advisory Committee meeting to review proposed biosimilar products referencing Avastin an...