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.
InfuTronix recalls its Nimbus infusion pump systems due to multiple potential failure modes that may include battery failure, upstream blockage (occlu...
FDA clears an Expanse ICE 510(k) for the ICE Aspiration System for use in peripheral thrombectomy procedures.
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FDA publishes a draft guidance to help sponsors expand eligibility for cancer drug clinical trials in terms of washout periods and concomitant medicat...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.
Federal Register notice: FDA makes available a revised draft guidance entitled Promotional Labeling and Advertising Considerations for Prescription Bi...
