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Hamburg To Step Down from FDA

2015-02-05 20:43:00| Food Processing

Long-serving commissioner will leave the food safety agency at the end of March.

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FDA Grants Breakthrough Therapy Designation To LentiGlobin For Treatment Of Beta-Thalassemia Major

2015-02-04 06:25:44| drugdiscoveryonline Home Page

bluebird bio, Inc. a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic and rare diseases, recently announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to LentiGlobin BB305 Drug Product for the treatment of transfusion-dependent patients with beta-thalassemia major

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Pfizer Receives U.S. FDA Accelerated Approval Of IBRANCE (palbociclib)

2015-02-04 06:14:13| drugdiscoveryonline Home Page

Pfizer Inc. recently announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval of IBRANCE (palbociclib), in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer as initial endocrine-based therapy for their metastatic disease

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FDA approves Pfizer drug to treat breast cancer in postmenopausal women

2015-02-04 01:08:56| Biotech - Topix.net

U.S. federal health regulators on Tuesday approved a highly anticipated medicine from Pfizer Inc. to treat postmenopausal women with a certain type of advanced breast cancer who have not already taken other drugs. The Food and Drug Administration approved Ibrance for women who have tumors that do not contain a protein known as HER-2.

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AngioDynamics Receives Expanded "No Chest X-Ray" FDA Clearance for Celerity Tip Location System

2015-02-03 11:30:45| Industrial Newsroom - All News for Today

ALBANY, N.Y.  AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced the U.S. Food and Drug Administration (FDA) cleared an expanded indication for the Celerity tip location...

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