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FDA Watch: Approval for Bristol-Myers Squibb; designation for CRISPR, Vertex

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Jan. 4.

Approvals

* Bristol-Myers Squibb Co.'s Sprycel, in combination with chemotherapy, for children ages one and up with Philadelphia chromosome-positive acute lymphoblastic leukemia. Sprycel is already approved to treat certain patients with similar subtypes of acute lymphoblastic leukemia.

SNL Image
FDA headquarters in Silver Spring, Md.
Source: Associated Press

Priority review

* Heron Therapeutics Inc.'s HTX-011, a non-opioid medication for pain. The application's target action date is April 30. The FDA previously granted HTX-011 breakthrough-therapy status.

Fast track

* CRISPR Therapeutics AG and Vertex Pharmaceuticals Inc.'s CTX001, for sickle cell disease. The FDA lifted a clinical hold on CTX001 in October 2018.

* ProQR Therapeutics NV's QR-421a, for vision loss associated with Usher syndrome type 2 and nonsyndromic retinitis pigmentosa caused by mutations in certain genes.