FDA issues an alert on a Kadesh recall of all lots of Puriton Eye Relief Drops due to non-sterile production conditions at the manufacturing facility.
FDA grants SpringWorks Therapeutics a fast track designation for nirogacestat, a selective gamma-secretase inhibitor under development for treating ad...
FDA approves a revised OTC version of Primatene Mist for a small group of asthma users.
FDA posts computer code for its MyStudies app so patients can input real-world data for clinical trials, registries, and other uses.
Federal Register notice: FDA makes available a draft guidance entitled Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety o...
The National Cybersecurity and Communications Integration Center says some Roche handheld medical devices are vulnerable to cyber attack.
FDA clears an MRI Interventions 510(k) for its latest software platform, ClearPoint 2.0.
FDA clears a MaxQ AI 510(k) for its Accipio Ix intracranial hemorrhage detection software.