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 an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease therapy Sucraid (sacrosidase) Oral Solution were f...
FDA sends a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aerosol after the company failed to respond to multip...
FDA warns St. Paul, MN-based HealthPartners Neuroscience Center Research and Innovation about good laboratory practice violations in its conduct of no...
Two Morgan Lewis attorneys explain a new FDA draft guidance on three-year drug exclusivity for new clinical investigations.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 warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, facility.
