Seven FDA drug, treatment approvals announced since the end of July:
- Rethymic — Enzyvant Therapeutics' drug is designed to treat children with congenital athymia, a rare immune disorder in which a child is born without a thymus, an organ that plays a critical role in helping the body learn to fight infections.
- Byooviz — The first biosimilar biosimilar drug to Roche's Lucentis treats several eye diseases. Byooviz is made by Samsung Bioepis.
- Vivistim Paired VNS System — A device, made by MicroTransponder, is intended to treat moderate to severe upper extremity motor deficits caused by a stroke.
- Comirnaty — Pfizer's COVID-19 vaccine, the first to receive full approval from the FDA. Moderna and Johnson & Johnson's COVID-19 vaccines haven't received full approval and are available under emergency use authorizations.
- Xywav — Jazz Pharmaceuticals' drug is used to treat a rare sleep condition.
- Nexviazyme — Genzyme's drug is used to treat Pompe disease, a rare genetic disease that causes muscle weakness and premature death from respiratory or heart failure.
- Semglee — Made by Mylan, it's the first interchangeable biosimilar insulin product approved in the U.S.