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FDA makes available a draft guidance entitled Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredient...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.
FDA publishes a draft guidance to help sponsors expand eligibility for cancer drug clinical trials in terms of washout periods and concomitant medicat...
Federal Register notice: FDA announces that OMB has approved an information collection entitled Electronic Records: Electronic Signatures.
