FDA issues Replimune another complete response letter, declining to approve its BLA for vusolimogene oderparepvec in combination with nivolumab for ad...
Representative Jake Auchincloss (D-MA) urges FDA whistleblowers to come forward to disclose instances of wrongdoing by agency managers.
FDA accepts a Telix Pharmaceuticals resubmitted NDA for TLX101-Px, an investigational PET imaging agent for glioma.
FDA cites significant manufacturing and quality control deficiencies at an active pharmaceutical ingredient facility operated by Orchid Pharma Limited...
FDA issues an early alert regarding a potential safety issue affecting certain sizing catheters manufactured by Cook Medical.
FDA cautions BioCorRx about false and misleading information on the Web site home page for its Lucemyra.
Vanda Pharmaceuticals says FDA should withdraw a legislative proposal in its budget package that the company says would lengthen NDA review times and ...
FDA and the device industry are nearing a final agreement on the next round of Medical Device User Fee Act (MDUFA VI) negotiations.
