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Approvals for Merck & Co., Astellas; designations for AstraZeneca, BridgeBio

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Approvals for Merck & Co., Astellas; designations for AstraZeneca, BridgeBio

Approvals and designations made by the U.S. Food and Drug Administration for the week ended Jan. 10.


* Merck & Co. Inc.'s Keytruda, as a single therapy for bladder cancer patients who are unresponsive to immunotherapy known as Bacillus Calmette-Guerin and who are ineligible or chose to not have their bladders surgically removed.

* Astellas Pharma Inc.'s Mycamine for candidemia, acute disseminated candidiasis, candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination, in children younger than 4 months.

* Blueprint Medicines Corp.'s Ayvakit, for patients with gastrointestinal stromal tumor who have a specific mutation of the platelet-derived growth factor receptor gene.

* Terumo Corp.'s Fred system, to treat brain aneurysms. The device was granted premarket approval.

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

Priority review

* AstraZeneca PLC's Farxiga, or dapagliflozin, to lessen the risk of cardiovascular death or the worsening of heart failure in adults with reduced ejection fraction, with or without type 2 diabetes.

Fast track

* BridgeBio Pharma Inc.'s infigratinib, as initial treatment for adult patients of a form of cholangiocarcinoma that spreads across tissue and cannot be treated surgically. The medicine also received the regulator's orphan-drug tag.

Orphan drug

* Intrexon Corp.'s PRGN-3006, for relapsed or refractory acute myeloid leukemia.

* Cellectar Biosciences Inc.'s CLR 131 for treating multiple types of cancers including lymphoplasmacytic lymphoma, also known as Waldenstrom macroglobulinemia.