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FDA reviewers raise safety concerns on a GlaxoSmithKline BLA for belantamab mafodotin which heads to an Oncologic Drugs Advisory C...[ Price : $8.95]
FDA publishes a guidance on modifications and revisions to an approved REMS.[ Price : $8.95]
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Toyama Chemical Co.s , Xepi...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Cancer Clinical Trial Eligibility Criteria: Brain Metastase...[ Price : $8.95]
FDA issues a draft guidance on Select Updates for Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the...[ Price : $8.95]
Federal Register notice. FDA makes available a final guidance entitled Cancer Clinical Trial Eligibility Criteria: Minimum Age Con...[ Price : $8.95]
FDA posts a drug safety-related labeling change for Eli Lilly and Incytes NDA for rheumatoid arthritis drug Olumiant to warn about...[ Price : $8.95]
FDA says it is planning to begin high-priority domestic inspections for medical products and other regulated products during the w...