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FDA Advisory Committee Recommends Approval Of BREO ELLIPTA For The Treatment Of COPD

2013-05-01 06:23:30| drugdiscoveryonline News Articles

GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to the US Food and Drug Administration (FDA) voted that the efficacy and safety data provide substantial evidence to support approval of BREO™ ELLIPTA™ as a once-daily inhaled treatment for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) (9 for, 4 against) and also for the reduction of COPD exacerbations in patients with a history of exacerbations (9 for, 4 against)

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Still no FDA approval for new drug to help patients wake up

2013-03-15 22:06:40| Biotech - Topix.net

The U.S. Department of Health and Human Services building which houses the Food and Drug Administration in Rockville, MD.

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FDA denies approval to expanded use of J&J/Bayer's Xarelto

2013-03-05 12:36:30| Chemicals - Topix.net

Johnson & Johnson said health regulators denied approval to an expanded use of its blood thinner, Xarelto, to reduce the risk of heart attacks and strokes in patients with acute coronary syndrome.

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FDA denies approval to expanded use of J&J/Bayer's Xarelto

2013-03-05 06:36:26| Biotech - Topix.net

Johnson & Johnson said health regulators denied approval to an expanded use of its blood thinner, Xarelto, to reduce the risk of heart attacks and strokes in patients with acute coronary syndrome.

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FDA denies approval to expanded use of J&J/Bayer's Xarelto

2013-03-05 05:49:55| Food - Topix.net

Johnson & Johnson said health regulators denied approval to an expanded use of its blood thinner, Xarelto, to reduce the risk of heart attacks and strokes in patients with acute coronary syndrome.

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