FDA warns Garland, TX-based Naturich Cosmetique about CGMP violations in its production of finished drugs.
FDA says Trividia Health has recalled 601 blood glucose meters that may have defective LCD displays.
FDA issues Xspray Pharma a complete response letter on its NDA for Dasynoc (dasatinib) and its use for treating chronic myeloid leukemia and acute lym...
A federal judge gives Eli Lilly a partial win in a lawsuit challenging FDAs refusal to classify retatrutide the companys investigational obesity ther...
A Hyman, Phelps & McNamara statistical analysis of FDA Warning Letters published by FDLI shows that nearly three-quarters of Warning Letters are issue...
AstraZeneca says its investigational drug baxdrostat met the primary endpoint in the Phase 3 Bax24 trial in patients with resistant hypertension.
Thirteen Republican House members call on HHS to lay off the CDER director, Office of Generic Drugs director, and others who were behind the approval ...
FDA clears restart of a pivotal clinical trial evaluating the NobleStitch EL system, a device-free, suture-mediated method for closing a patent forame...
