Federal Register notice: FDA announces a 7/11 public workshop entitled Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic ...
FDA warns Rosenberg, TX-based Seatex about CGMP violations in its manufacturing of finished drugs.
FDA says it no longer is requiring HCT/P donor screening for the Zika virus because the virus no longer has sufficient incidence or prevalence to affe...
The Medical Device Manufacturers Association requests changes to several aspects of an FDA draft guidance on premarket cybersecurity.
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 formulation of Opdivo (nivo...
Federal Register notice: FDA reinstates an information collection entitled Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation...
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...
