A Paragon Health Institute white paper suggests an approach to regulating healthcare artificial intelligence that it says builds on existing FDA regul...
Based on FDA feedback, NeuroSense Therapeutics says it will begin a Phase 3 study of PrimeC (ciprofloxacin and celecoxib) for treating amyotrophic lat...
Johnson & Johnson reports data from its Phase 3 CARTITUDE-4 study that show Carvykti significantly increased minimal residual disease (MRD) negativity...
Two men are convicted of securities fraud in a case involving misrepresented submissions to FDA for a drug purportedly intended to treat HIV and Covid...
FDA warns Chinas Guangzhou Four Es Scientific Co. about CGMP violations in its production of finished drugs.
Getinge/Maquet issues a Class 1 recall (device correction) to inform users about important safety information for its VasoView HemoPro 2 Endoscopic Ve...
Four Ropes & Gray attorneys analyze a 9th Circuit Appeals Court decision backing FDA regulation of stem cell products and raise the possibility of fut...
FDA denies a Metacel petition asking the agency to require flavoring tests for generic forms of the companys Ozobax.
