Law firm Sheppard breaks down some of FDAs proposals in its budget documents that industry should keep a close eye on, including new DTC ad authoritie...
FDA announces a 5/18 virtual public workshop aimed at advancing the use of novel surrogate endpoints in developing treatments for rare diseases.
Insmed discontinues development of its drug candidate brensocatib for hidradenitis suppurativa after a mid-stage clinical trial failed to meet its pri...
Baker Hostetler attorney Winston Kirton says life sciences companies that are active in both the U.S. and the EU need to change their view of supply c...
A Clinical Trial Vanguard online column explains how a 2022 FDA master protocol guidance has not kept pace with non-oncology basket trial developments...
FDA removes partial clinical hold against MacroGenics Phase 2 LINNET study evaluating the investigational cancer therapy lorigerlimab.
An FDA Matters column calls on FDA to fully enforce the laws against mass compounding of approved drugs that are not in shortage.
FDA warns Glens Falls, NY-based Medline Industries about Quality System violations in its manufacturing and assembly of cardiovascular procedure kits.
