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FDA says it no longer is requiring HCT/P donor screening for the Zika virus because the virus no longer has sufficient incidence o...[ Price : $8.95]
The Medical Device Manufacturers Association requests changes to several aspects of an FDA draft guidance on premarket cybersecuri...[ Price : $8.95]
FDA revises its user fee review action date from 2/28/2025 to 12/29/2024 for a Bristol Myers Squibb BLA for a subcutaneous formula...[ Price : $8.95]
Federal Register notice: FDA reinstates an information collection entitled Yale-Mayo Clinic Centers of Excellence in Regulatory Sc...[ Price : $8.95]
FDA warns Gaithersburg, MD-based Akan Biosciences about multiple violations in its manufacturing and distribution of Ayama, an adi...[ Price : $8.95]
GSK says two Phase 3 clinical trials evaluating severe asthma treatment hopeful depemokimab met their primary endpoints of reducin...[ Price : $8.95]
Federal Register notice: FDA announces that its previously postponed 5/16 meeting of the Vaccines and Related Biological Products ...[ Price : $8.95]
Sen. Rand Paul and Rep. Brad Finstad introduce a Congressional Review Act resolution to block an FDA proposed rule on oversight of...