Eisai files a supplemental BLA for monthly Leqembi (lecanemab-irmb) intravenous maintenance dosing in Alzheimers disease patients.
FDA posts a final guidance entitled Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies.
Federal Register notice: FDA makes available a final guidance entitled Providing Regulatory Submissions in Electronic Format: IND Safety Reports.
FDA clears Abbotts i-STAT TBI (traumatic brain injury) cartridge to be used with whole blood to assess patients with suspected concussion at the patie...
Pharmaceutical Research and Manufacturers of America says FDAs recent draft guidance on cell and gene therapy potency assurance needs additional speci...
FDA clears an Otsuka Pharmaceutical and Click Therapeutics 510(k) for Rejoyn, a prescription digital therapeutic authorized for treating major depress...
Federal Register notice: FDA makes available a draft guidance entitled Animal Studies for Dental Bone Grafting Material Devices Premarket Notificatio...
Thoratec recalls its HeartMate Touch Communication System due to software design issues.
