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Approvals for Merck & Co., Bayer; designations for Momenta, Nektar Therapeutics

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Aug. 2.


* Merck & Co. Inc.'s Keytruda for squamous cell carcinoma of the esophagus that has spread to other parts, with the tumors expressing the PD-L1 protein, as determined by an FDA-approved test.

* Bayer AG and Orion Oyj's Nubeqa for castration-resistant prostate cancer that has not spread to other parts of the body.

* Agilent Technologies Inc.'s PD-L1 IHC 22C3 pharmDx diagnostic test to identify patients with esophageal squamous cell carcinoma who are eligible for treatment with Merck & Co. Inc.'s Keytruda.

* Zeus Scientific Inc.'s Zeus Elisa enzyme immunoassay tests to diagnose Lyme disease.

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

Fast track

* Momenta Pharmaceuticals Inc.'s M281 for hemolytic disease of the fetus and newborn.

Breakthrough therapy

* Nektar Therapeutics' NKTR-214 in combination with Bristol-Myers Squibb Co.'s Opdivo for previously untreated skin cancer that cannot be removed completely through surgery or has spread to other parts of the body.

Other designations

* Orphan drug, for Genfit SA's elafibranor for primary biliary cholangitis.

* Orphan drug, for Neuren Pharmaceuticals Ltd.'s NNZ-2591 for Phelan-McDermid syndrome, Angelman syndrome and Pitt Hopkins syndrome.

* Regenerative medicine, for Orchard Therapeutics PLC's gene therapy OTL-103 for Wiskott-Aldrich syndrome.