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Approvals for J&J, Roche; designations for Xynomic, Achillion Pharmaceuticals

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Approvals for J&J, Roche; designations for Xynomic, Achillion Pharmaceuticals

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.

SNL ImageFDA headquarters in Silver Spring, Md.
Source: AP Photo

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.