Approvals and designations made by the U.S. Food and Drug Administration for the week ended Aug. 16.
* Roche Holding AG's Rozlytrek for non-small cell lung cancer that has spread to other parts of the body and who express ROS1.
* Roche's Rozlytrek, for patients whose solid tumors have certain gene rearrangements called NTRK gene fusion, that do not have a known acquired resistance mutation. The drug received accelerated approval for this indication.
* AbbVie Inc.'s Rinvoq, for adults with moderately to severely active rheumatoid arthritis who cannot take or have had an inadequate response to the commonly used immunosuppressive drug methotrexate.
* Celgene Corp.'s Inrebic for patients with intermediate or high-risk myelofibrosis. The approval was given to Celgene's life sciences arm Impact Biomedicines Inc.
* Zimmer Biomet Holdings Inc.'s product called the Tether, for children with scoliosis. The treatment got clearance under the FDA's humanitarian device exemption pathway.
* Expanded approval, for Edwards Lifesciences Corp. Sapien 3 and Sapien 3 Ultra along with Medtronic PLC's CoreValve Evolut R and CoreValve Evolut PRO transcatheter heart valves for patients with aortic stenosis who are at low risk of open-heart surgery.
FDA headquarters in Silver Spring, Md.
* Windtree Therapeutics Inc.'s istaroxime for acute heart failure.
* Akari Therapeutics PLC's nomacopan for hematopoietic stem cell transplant associated thrombotic microangiopathy, or HSCT-TMA, in children.
* AstraZeneca PLC's Calquence as a single therapy for adults with chronic lymphocytic leukemia.
* Qualified infectious disease product, for Daré Bioscience Inc.'s antibacterial gel DARE-BV1 for bacterial vaginosis.