FDA warns that Chemigroup France is marketing Skin-Cap aerosol spray products that may contain undisclosed steroids.
FDA clears an Exactech 510(k) for the Truliant Porous Tibial Tray, a 3D-printed tibial knee implant.
FDA clears an Imbed Biosciences 510(k) for its Microlyte Ag/Lidocaine, an antimicrobial wound dressing that integrates lidocaine for managing painful ...
AstraZeneca provides four comments to the FDA docket on considerations for generative artificial intelligence/machine learning over a medical devices ...
GE HealthCare subsidiary Datex-Ohmeda recalls its Giraffe OmniBed and Giraffe OmniBed CareStation to update their use instructions.
UCB says its investigational Alzheimers drug bepranemab missed the primary endpoint in a Phase 2a trial but hit secondary endpoints in some patient su...
Verastem Oncology completes a rolling NDA submission for the combination of avutometinib and defactinib for adults with recurrent KRAS mutant low-grad...
The DC federal court tosses a Jazz Pharmaceuticals suit against FDA over the agencys approval of Avadels narcolepsy drug Lumryz before the end of the ...
