7 recent drug, device approvals

Seven FDA drug, treatment approvals announced since the end of July:

  1. 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.

  2. Byooviz  — The first biosimilar biosimilar drug to Roche's Lucentis treats several eye diseases. Byooviz is made by Samsung Bioepis.

  3. Vivistim Paired VNS System — A device, made by MicroTransponder, is intended to treat moderate to severe upper extremity motor deficits caused by a stroke.

  4. 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.

  5. Xywav — Jazz Pharmaceuticals' drug is used to treat a rare sleep condition.

  6. 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.

  7. Semglee — Made by Mylan, it's the first interchangeable biosimilar insulin product approved in the U.S.

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