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.
Two Morgan Lewis attorneys analyze a recent FDA guidance on how it will implement its drug platform technology designation program.
Ultragenyx and BioMereo say their setrusumab showed positive results in the Phase 2 portion of the Orbit study in patients with the complex bone and t...
FDA gives traditional approval to Lillys Retevmo for some thyroid cancers in patients aged two and up.
A House Appropriations subcommittee slashes $450 million (6%) from FDAs fiscal year 2025 budget.
FDA clears an Avicenna.AI 510(k) for its CINA-VCF, a triage and notification artificial intelligence tool for detecting unsuspected vertebral compress...
