Federal Register notice: FDA seeks comments concerning abuse potential and the impact of scheduling changes on availability for medical use of eight d...
Federal Register notice: FDA makes available a final guidance entitled Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Imp...
Drgerwerk recalls its Drger Carina Sub-Acute Care Ventilators due to the potential for contamination of the breathing gas.
FDA grants ABM Therapeutics an orphan drug designation for ABM-1310, a novel small molecule BRAF inhibitor for treating patients with glioblastoma.
Federal Register notice: FDA makes available a final guidance entitled Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the...
Federal Register notice: FDA determines that KTAB (potassium chloride) extended-release tablets were not withdrawn due to safety or effectiveness conc...
Federal Register notice: FDA permanently debars Raidel Figueroa from providing services in any capacity to a person that has an approved or pending dr...
Regeneron says it has discontinued enrollment in a Phase 1 prostate cancer study of REGN5678, which is studying the combination use with a full-dose o...
