FDA Oncology Drugs Division director Harpreet Singh leaves the agency to join Precision for Medicine as chief medical officer.
Public Citizen sues FDA to force it to act on a six-year-old petition seeking labeling changes for SSRIs and SNRIs to highlight the risk of sexual sid...
FDA says the Hologic recall (correction) of BioZorb markers is Class 1.
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 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...
