Approvals and designations made by the U.S. Food and Drug Administration for the week ended May 17.
* Pfizer Inc.'s Fragmin as the first heparin blood thinner for use in infants as young as one month with venous thromboembolism.
* AbbVie Inc.'s Venclexta plus Roche Holding AG's Gazyva for chronic lymphocytic leukemia.
* Merck KGaA's Bavencio in combination with Pfizer's Inlyta as the first-line treatment for patients with advanced renal cell carcinoma.
* Eli Lilly and Co.'s Cyramza for hepatocellular carcinoma previously treated with Bayer AG's Nexavar.
* Regeneron Pharmaceuticals Inc.'s Eylea injection for all stages of diabetic retinopathy.
* Haemonetics Corp.'s TEG 6s Hemostasis analyzer system to evaluate the hemostasis condition of adult trauma patients.
|FDA headquarters in Silver Spring, Md.|
|Source: Associated Press|
* Cellectar Biosciences Inc.'s CLR 131 for patients with multiple myeloma who have received at least three or more lines of prior therapy but whose disease did not go away.
* Athersys Inc.'s MultiStem cell therapy for acute respiratory distress syndrome.
* Homology Medicines Inc.'s experimental gene therapy HMI-102 for adults with phenylketonuria.
* Celgene Corp.'s Pomalyst for patients with HIV positive Kaposi sarcoma who have previously received systemic chemotherapy, as well as patients with HIV‐negative Kaposi sarcoma.
Other designations: orphan drug
* Mustang Bio Inc. and Nationwide Children's Hospital Inc.'s MB-108 for malignant glioma.