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...
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The Advanced Medical Technology Association says FDAs new draft guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-S...
