Federal Register notice: FDA issues a priority review voucher to Enzyvant Therapeutics in response to its approval of a qualified rare pediatric disea...
As HHS suggests increasing access to buprenorphine to treat opioid addiction, manufacturer Purdue Pharma emphasizes its addiction risks.
The CDER Office of Prescription Drug Promotion says it will study how consumers and healthcare professionals react to promotional materials using the ...
Millions of J&J Covid vaccine doses are reported to be sitting in the Emergent facility in Baltimore waiting for FDA to authorize shipment.
FDA clears a NeuroLogica 510(k) for its Auto Lung Nodule Detection (ALND) tool, a computer-assisted detection device for detecting pulmonary nodules.
Federal Register notice: FDA announces the revocation of the Emergency Use Authorization issued to Life Technologies Corporation for the TaqPath Covid...
Two Morrison Foerster attorneys list five takeaways from an FDA virtual public meeting on artificial intelligence/machine learning transparency.
CDER associate director for controlled substances Marta Sokolowska shares issues raised at an FDA/Duke-Margolis Center for Health Policy workshop on s...