FDA tells Karyopharm clinical trial results are unlikely to support approval of its selinexor as maintenance therapy for endometrial cancer patients f...
Federal Register notice: FDA posts a final guidance entitled Inclusion of Older Adults in Cancer Clinical Trials.
FDA approves a Johnson & Johnson Vision Cares Acuvue Theravision with Ketotifen, a drug-eluting contact lens with the antihistamine ketotifen to help ...
FDA clears a SurGenTec 510(k) for its Ion Screw and its use as a stand-alone spine fixation implant.
Attorney Nick Oberheiden lays out a 10-step strategy for companies to use in responding to an FDA Warning Letter.
FDA grants Pfizer a breakthrough therapy designation for its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, and its use ...
Federal Register notice: FDA makes available a final guidance entitled Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Develo...
Four stakeholders make suggestions for an FDA draft guidance on using registries as part of real-world data in drug and biologic regulatory decision-m...