FDA Approval

PITTSBURGH, December 1, 2011 - - Product also 'prequalified' by WHO as a second-line treatment option - Mylan Inc.

GENEVA, November 30, 2011 - Afixed-dose combination therapy to combat malaria, Eurartesim, (dihydroartemisinin-piperaquine) theproductof Italian research conducted bySigma-TauandMMV, approved by the European Medicines Agency (EMA) Therapy with a simple dosage regimen, up to 3 tablets once a day for 3 days.

TIRAT CARMEL, Israel, November 27, 2011 - - Evidence Sufficient to Support the Use of This Procedure With Normal Arrangements - InSightec Ltd announced that NICE, the National Institute for Health and Clinical Excellence of the NHS in the UK, announced new favorable guidelines for the treatment of uterine fibroids using MR guided Focused Ultrasound.

LEXINGTON, Massachusetts, November 22, 2011 - Approval Will Add Substantial Manufacturing Capacity for Rare Disease Products Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has submitted regulatory filings with both the European Medicines Agency (EMA) and the U.S.

GENEVA and PLAN-LES-OUATES, Switzerland, November 21, 2011 - BELOTERO Balance has now been approved by the US Food and Drug Administration (FDA) for injection into the mid-to-deep dermis to correct moderate-to-severe facial wrinkles and folds such as nasolabial folds.
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