Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Med...
Elekta Instrument recalls its Disposable Biopsy Needles from one batch (837838839) because they possibly contain some microscopic stainless steel debr...
FDA approves Pfizers Beqvez (fidanacogene elaparvovec-dzkt), a gene therapy for treating adults with moderate to severe hemophilia B.
Federal Register notice: FDA creates a public docket entitled Promoting Effective Drug Development: Identifying Opportunities and Priorities for the F...
FDA makes available a draft guidance entitled Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredient...
FDA grants Roivios a breakthrough device designation for its JuxtaFlow Renal Assist Device and its use in safeguarding kidney function for patients un...
FDA approves a Medtronic PMA for the Inceptiv closed-loop rechargeable spinal cord stimulator for treating chronic pain.
FDA grants fast track designation to Compass CTX-009 that is in a Phase 2 study with paclitaxel to treat some biliary tract tumors.
