FDA says it has worked with EPA and USDA to develop a biotechnology regulatory reform program as required by a presidential Executive Order.
FDA grants in part and denies in part a 14-year-old Kaiser Permanente petition on the development, implementation, and evaluation of REMS.
FDA grants China-based Mabwell an orphan drug designation for its novel Nectin-4-targeting antibody-drug conjugate 9MW2821 for treating esophageal can...
Six Hogan Lovells attorneys comprehensively analyze the new FDA final rule on laboratory-developed tests and predict industry stakeholder litigation c...
The House Energy and Commerce Committee announces a 5/22 hearing titled Check Up: Examining FDA Regulation of Drugs, Biologics, and Devices, which wil...
FDA approves Geneoscopys colorectal cancer stool-based screening test ColoSense for those aged 45 years and older with an average risk for developing ...
FDA announces a 6/10 Peripheral and Central Nervous System Drugs Advisory Committee meeting to vote on an Eli Lilly BLA for Alzheimers drug donanemab....
Federal Register notice: FDA makes available a draft guidance entitled REMS Logic Model: A Framework to Link Program Design With Assessment.
