FDA issues a draft guidance to help applicants filing NDAs or BLAs or their supplements understand the evidence to be provided to demonstrate effectiv...
FDA approves Astellas Padcev, a new type of treatment for advanced urothelial cancer.
FDA says it will use information in a National Academies report to work with medical professional societies on evidence-based guidelines for prescribi...
Legislators reintroduce the Affordable Drug Manufacturing Act to help lower drug costs.
The Trump administration proposes allowing importation of certain prescription drugs from Canada by states, wholesalers, pharmacists, or non-federal g...
FDA says patients with respiratory risk factors may be at risk for serious breathing difficulties if they use any of the gabepentinoid drugs.
Attorney James Beck says FDA is breaking with long-established practice to encourage truthful promotion to doctors of off-label uses of FDA-approved d...
FDA Webview posts summaries of the FDA Warning Letters released during our holiday break.