Two Morgan Lewis attorneys explain a new FDA draft guidance on three-year drug exclusivity for new clinical investigations.
Senate appropriators delay consideration of a fiscal 2027 spending bill that would fund FDA, after a broader dispute over a Republican reconciliation ...
FDA has accepted a Letter of Intent for the first in silico artificial intelligence-driven digital liver model for predicting drug-induced liver injur...
FDA accepts for priority review a Roche NDA for giredestrant, an investigational oral endocrine therapy for patients with early-stage estrogen recepto...
FDA issues Cingulate a complete response letter on the company's NDA for CTx-1301, an investigational treatment for attention-deficit/hyperactivity di...
FDA issues an early alert regarding a potentially high-risk problem involving certain Abiomed catheter introducer kits used with the companys Impella ...
FDA warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, facility.
FDA warns Mexicos Laboratorios Jaloma about CGMP violations in its production of finished drugs.
