Granules India Ltd tightens oversight of its manufacturing operations at its largest facility based on FDA-documented compliance issues outlined in a ...
FDA cites GMP deficiencies at a facility operated by Thermo Fisher Scientific (Patheon Italia unit) in Ferentino, Italy.
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.
