Approvals and designations made by the U.S. Food and Drug Administration for the week ended Jan. 4.
* 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.
|FDA headquarters in Silver Spring, Md.|
|Source: Associated Press|
* 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.
* 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.