Pharmaceutical Research and Manufacturers of America says FDAs recent draft guidance on cell and gene therapy potency assurance needs additional speci...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Federal Register notice: FDA makes available a draft guidance entitled Animal Studies for Dental Bone Grafting Material Devices Premarket Notificatio...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.
FDA says its electronic Submission Template And Resource system is now available for voluntary 513(g) (device classification) requests for information...
FDA removes a partial clinical hold against ProJenX and its Study PRO-101, a hybrid Phase 1 clinical trial evaluating prosetin in healthy volunteers a...
FDA approves Roches cobas malaria test for use on the cobas 6800/8800 Systems to aid healthcare professionals in reducing potential risks of patient i...
In the wake of this weeks U.S. Supreme Court oral arguments on the abortion drug mifepristone, a new Axios/Ipsos poll finds that most Americans say th...
