Magellan Diagnostics (Billerica, MA) agrees to pay $40 million to resolve criminal charges relating to its concealment of a device malfunction that pr...
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 announces a 7/11 public workshop entitled Evaluating Immunosuppressive Effects of In Utero Exposure to Drug and Biologic ...
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...
