Federal Register notice: FDA makes available a revised draft guidance entitled Conducting Remote Regulatory Assessments Question and Answers.
Federal Register notice: FDA makes available a final document entitled Best Practices for FDA Staff in the Postmarketing Safety Surveillance of Human ...
FDA says that beginning 3/8, Pfizers Paxlovid that is labeled under a 12/2021 emergency use authorization will no longer be authorized for adults, and...
U.S. Senator Tammy Baldwin (D-WI) writes the four biggest drug companies marketing asthma inhalers urging them to stop unfairly blocking generics from...
Merck says its Phase 3 KEYNOTE-564 trial evaluating Keytruda (pembrolizumab) as an adjuvant treatment in patients with renal cell carcinoma saw an imp...
Philips Respironics and FDA reach an agreement on the terms of a consent decree over the companys struggles to resolve issues surrounding its troubled...
FDA issues a guidance entitled Human Gene Therapy Products Incorporating Human Genome Editing.
Azurity Pharmaceuticals recalls one lot of narcolepsy drug Zenzedi CII (dextroamphetamine sulfate tablets, USP) 30 mg after a report was received that...
