FDA publishes a draft guidance recommending how to approach bridging in NDAs or BLAs for some drug-device and biologic-device combination products.
FDA issues a draft guidance to help applicants filing NDAs or BLAs or their supplements understand the evidence to be provided to demonstrate effectiv...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 says that allowing chemically synthesized peptides to use the biosimilar or interchangeable approval pathway will benefit consumers by bringing fo...
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.