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Approvals for Pfizer, AbbVie; designations for Cellectar, Celgene

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Approvals for Pfizer, AbbVie; designations for Cellectar, Celgene

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.

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

Fast track

* 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.

Breakthrough therapy

* 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.