FDA approves Regenerons Dupixent (dupilumab) for treating eosinophilic esophagitis in adults and pediatric patients 12 years and older.
House Energy and Commerce Committee Republican leaders ask FDA commissioner Robert Califf to answer questions about a growing trend for clinical trial...
FDA publishes a draft guidance on possible enforcement discretion so dietary supplement companies can correct past failures to submit required new die...
CDER Office of Pharmaceutical Quality director Michael Kopcha says the agency is working on regulations to help companies become more comfortable with...
CDRH announces a new 510(k) Sterility Change Master File Pilot Program that is intended to give interested companies that terminally sterilize single-...
FDA publishes a draft guidance to help develop, maintain, and implement risk management plans to assist in preventing human drug shortages.
FDA principal deputy commissioner Janet Woodcock explains the components of the agencys new Enterprise Modernization Action Plan.
FDA updates its communications about Philips Respironics recalls of ventilators and BiPAP and CPAP machines.