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Sidley Austin attorneys pull five takeaways, including challenges, from a recent FDA draft guidance on off-label communications between companies and ...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...
FDA accepts for priority review an X4 Pharmaceuticals NDA for once-daily, oral mavorixafor to treat individuals aged 12 and older with WHIM (Warts, Hy...
FDA approves a Tenaya Therapeutics IND for the company to begin a Phase 1b trial of TN-401, an adeno-associated virus serotype 9-based investigational...
