FDA warns Gaithersburg, MD-based Akan Biosciences about multiple violations in its manufacturing and distribution of Ayama, an adipose-derived stromal...
GSK says two Phase 3 clinical trials evaluating severe asthma treatment hopeful depemokimab met their primary endpoints of reducing the annualized rat...
Federal Register notice: FDA announces that its previously postponed 5/16 meeting of the Vaccines and Related Biological Products Advisory Committee h...
Sen. Rand Paul and Rep. Brad Finstad introduce a Congressional Review Act resolution to block an FDA proposed rule on oversight of laboratory-develope...
FDA approves a 200 mg subcutaneous route of administration of GSKs Benlysta (belimumab) for patients five years of age and older with active systemic ...
The Advanced Medical Technology Association says FDAs new draft guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-S...
Federal Register notice: FDA issues a final order reclassifying the ultrasound cyclodestructive device, a postamendments Class 3 device (product code ...
Federal Register notice: FDA announces the withdrawal of the Center for Veterinary Medicines Program Policy and Procedures Manual Guide 1240.3605 Regu...
