FDA reviewers raise safety concerns on a GlaxoSmithKline BLA for belantamab mafodotin which heads to an Oncologic Drugs Advisory Committee meeting 7/1...
FDA publishes a guidance on modifications and revisions to an approved REMS.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Toyama Chemical Co.s , Xepi (ozenoxacin).
Federal Register notice: FDA makes available a final guidance entitled Cancer Clinical Trial Eligibility Criteria: Brain Metastases.
FDA issues a draft guidance on Select Updates for Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign...
Federal Register notice. FDA makes available a final guidance entitled Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Incl...
FDA posts a drug safety-related labeling change for Eli Lilly and Incytes NDA for rheumatoid arthritis drug Olumiant to warn about hypersensitivity re...
FDA says it is planning to begin high-priority domestic inspections for medical products and other regulated products during the week of 7/20.