FDASIA Section 705 Annual Reports

CGMP/Finished Pharmaceuticals/Adulterated

The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis (AFRS) with a history of sino-nasal surgery or for whom surgery is not advisable. This is the first approval for

Quarterly IID Change Log displays changes made since the previous quarterly IID publication.

Stories illustrating how regulatory science impacts the lives and health of people

Clinical Investigator (Sponsor)

CGMP/Finished Pharmaceuticals/Adulterated