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Novartis’ blood disorder drug gets FDA approval for expanded use

The U.S. Food and Drug Administration expanded the use of Novartis AG’s low platelets drug Promacta to treat patients with a rare, genetic blood disorder.

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FDA approves Rigel Pharmaceuticals’ drug for rare bleeding disorder

The U.S. Food and Drug Administration approved Rigel Pharmaceuticals Inc.’s treatment for a rare bleeding disorder.

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Rigel Pharma Awaits FDA Approval for Tavalisse, Builds Commercial Org for Drug Launch

The first half of 2018 will be pivotal for Bay Area-based Rigel Pharmaceuticals Inc. as the company awaits regulatory approval for its rare blood disorder drug and builds out the internal infrastructure to commercialize the product.

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Novartis’ Promacta receives FDA breakthrough designation for new indication

Promacta received breakthrough therapy designation from the FDA for first-line treatment of SAA.

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FDA allows Alnylam to restart hemophilia treatment trials

The U.S. Food and Drug Administration allowed Alnylam Pharmaceuticals Inc. to restart clinical trials on a drug to treat patients with a rare bleeding disorder.

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Amgen Receives Positive CHMP Opinion To Expand Use Of Nplate

Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion to expand the current indication for Nplate.

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Shire to Consolidate 3,000+ Jobs Over 4 Years to 2 Massachusetts Sites

Dublin, Ireland-based Shire plans to consolidate more than 3,000 staffers spread out at over half-a-dozen locations across Massachusetts to two campuses in Cambridge and Lexington.

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Rigel’s bleeding disorder drug clears key trial

Rigel Pharmaceuticals Inc. said its experimental drug to treat a bleeding disorder met its main goal in the first of two late-stage trials.

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FDA approves Baxalta’s treatment for common bleeding disorder

The U.S. Food and Drug Administration on Tuesday approved Baxalta Inc’s Vonvendi, making it the first engineered protein-based treatment for the world’s most common inherited bleeding disorder. Vonvendi treats Willebrand disease, which is caused by the deficiency or defect in von Willebrand factor, a protein that is critical for blood clotting. The disease affects about […]

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