The Segwick Recall Index shows that both medical device and drug recalls dropped in the second quarter of 2023 from the first quarter.
FDA grants Nuvectis Pharmas NXP800 an orphan drug designation for treating biliary tract cancer.
FDA clears a Pentax Medical 510(k) for its Inspira 4K video processor and the i20c video endoscope.
FDA says it will give priority review to a Servier sNDA seeking a new indication for Tibsovo to treat some adult myelodysplastic syndrome patients.
The Fifth Circuit Court of Appeals rules that the abortion drug mifepristone can remain on the market while litigation continues.
Attorney Douglas Farquhar says an FDA trend toward more enforcement discretion for drug company inspections with official action indicated results may...
The FDA National Center for Toxicological Research says initial results from its new PathologAI initiative in preclinical animal studies are encouragi...
