Approvals and designations made by the U.S. Food and Drug Administration for the week ended Sept. 27.
Approvals
* Johnson & Johnson and Genmab A/S' Darzalex, in combination with dexamethasone, thalidomide and chemotherapy drug bortezomib for newly diagnosed patients with multiple myeloma who are candidates for autologous stem cell transplant.
* Roche Holding AG's Rituxan, combined with glucocorticoids, for granulomatosis with polyangiitis and microscopic polyangiitis in children aged two years or older.
* Bavarian Nordic A/S' smallpox and monkeypox vaccine Jynneos for adults, including people with weak immune systems and eczema.
* Exact Sciences Corp.'s Cologuard to detect colon cancer in patients aged 45 years and older.
* Medtronic PLC's Evolut Pro+ replacement heart valve for aortic stenosis.
* Abbott Laboratories' Architect Stat High Sensitivity Troponin-I blood test to help detect heart attacks.
* Abiomed Inc.'s premarket application for Impella 5.5 heart pump for patients experiencing cardiogenic shock.
* Abbott Laboratories' Proclaim XR device for chronic pain.
* Cardiovascular Systems Inc.'s ViperWire to provide superelasticity and flexibility to physicians treating counter coronary artery calcification with the company's Diamondback 360 system. The FDA approved Cardiovascular Systems' premarket application.
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Fast track
* Xynomic Pharmaceuticals Holdings Inc.'s abexinostat as a fourth-line treatment of relapsed or refractory follicular lymphoma.
* Aldeyra Therapeutics Inc.'s ADX-2191 for proliferative vitreoretinopathy.
Breakthrough therapy
* Achillion Pharmaceuticals Inc.'s danicopan for paroxysmal nocturnal hemoglobinuria.
Other designations
* Rare pediatric disease designation, for Mateon Therapeutics Inc.'s trabedersen for diffuse intrinsic pontine glioma.

FDA headquarters in Silver Spring, Md.