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Federal Register notice: FDA makes available a draft guidance entitled REMS Logic Model: A Framework to Link Program Design With Assessment.
The House Oversight Committee puts pressure on FDA and its oversight of imported Chinese and other foreign active pharmaceutical ingredients and finis...
FDA warns Chinas Bioptimal International about multiple violations at a Singapore facility manufacturing two unapproved catheters.
