FDA says it has issued a final report from the Drug Supply Chain Security Act pilot project.
FDA publishes an International Council for Harmonization question-and-answer guidance responding to questions about its M10 bioanalytical method valid...
FDA grants accelerated approval to Bristol Myers Squibbs Augtyro to treat some adults and pediatric patients with neurotrophic tyrosine receptor kinas...
Megadyne recalls its Megadyne Mega Soft Pediatric Patient Return Electrodes after receiving reports about patients being burned during electrosurgery ...
FDA says Revive Therapeutics should submit an IND for a clinical trial of its bucillamine as a treatment for Long Covid.
Federal Register notice: FDA reopens the comment period on an 11/20/2023 request for information that is intended to better understand the status of t...
Federal Register notice: FDA seeks comments on an information collection extension entitled Human Drug Compounding, Repackaging, and Related Activitie...
A New Jersey federal judge orders five Teva ProAir patents removed from the FDA Orange Book.
