FDA commissioner Scott Gottlieb says the agency should have a new way of approving new opioid drug submissions that considers them in a different clas...
FDA grants Imbrium Therapeutics an orphan drug designation for its investigational drug EDO-S101 (tinostamustine), a potentially first-in-class therap...
FDA approves a Novartis NDA for Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis.
FDA issues a guidance to help applicants know where to place pediatric information in labeling for prescription drug and biological products.
DC federal court chief judge says both FDA and the Judge Rotenberng Educational Center have not fully met their responsibilities under the Freedom of ...
Oncology Center of Excellence director Richard Pazdur describes the centers activities over the last two years as part of its 2018 annual report.
Federal Register notice: FDA announces a 4/29 regional public meeting entitled U.S. Food and Drug Administration and Health Canada Joint Regional Cons...
Federal Register notice: FDA announces a 5/2 annual meeting of the Reagan-Udall Foundation that will discuss its activities and how they support FDA.