PhRMA says it supports FDA and the International Council for Harmonization revision of the E2D guidance on post-approval case safety reporting.
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 ...
FDA warns Rosenberg, TX-based Seatex about CGMP violations in its manufacturing of finished drugs.
