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.
FDA publishes a draft International Council for Harmonization M15 guidance on model-informed drug development principles.
