FDAs Cellular, Tissue, and Gene Therapies Advisory Committee supports Vertex Pharmaceuticals and CRISPR Therapeutics safety assessments on their sickl...
An FDA post reviews 50 years of agency involvement in cannabis research and predicts the increase seen in recent years will continue.
A Florida federal judge sentences Marina Sievert to two years in federal prison for mail fraud and introducing into interstate commerce a foreign unap...
Tonix Pharmaceuticals discontinues the development program for major depressive disorder candidate TNX-601 ER based on disappointing efficacy results ...
Sidley Austin attorneys pull five takeaways, including challenges, from a recent FDA draft guidance on off-label communications between companies and ...
FDA issues NATCO Pharma an eight-item Form FDA-483 after concluding an inspection of the firms Telangana, India, manufacturing facility 10/18.
FDA warns Omaha, NE-based Ali Pharmaceutical Manufacturing about significant CGMP deviations for active pharmaceutical ingredients.
FDA warns San Diego, CA-based Samm Solutions about objectionable conditions in its role as the testing facility for two nonclinical laboratory studies...
