fda
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US FDA grants priority review to Bayer’s Xarelto
Bayer, together with its cooperation partner, Janssen Research & Development, announced that the US FDA has granted priority review designation to the supplemental New Drug Application (sNDA) filed on December 29, 2011 for the oral anticoagulant Xarelto.
fda | 09 April 2012
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US FDA clears investigational new drug application, phase 2B trial for Immuron’s NASH/Fatty liver therapeutic
Immuron announced that the United States Food and Drug Administration (US FDA) had cleared an Investigational New Drug (IND) submission to commence a Phase 2b clinical trial of its bovine colostrum-derived therapeutic (IMM-124E) for the treatment of Non-Alcoholic Steatohepatitis (NASH) and Fatty Liver.
fda | 06 March 2012
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US FDA approves Bayer’s Xarelto (rivaroxaban)
Bayer HealthCare announced that the US Food and Drug Administration (FDA) has approved once-daily Xarelto (rivaroxaban) to protect patients with non-valvular atrial fibrillation from the risk of stroke and systemic embolism. Rivaroxaban is the only oral anticoagulant now approved in the US that provides the benefits of once-daily fixed dosing and no need for routine blood monitoring, two important considerations when treatment needs to be maintained over time.
fda | 03 January 2012
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Abbott receives FDA approval for ALK gene test for lung cancer therapy selection
Abbott announced it has received approval from the US Food and Drug Administration (FDA) for a new molecular diagnostic test designed to detect rearrangements of the anaplastic lymphoma kinase (ALK) gene in non-small-cell lung cancer (NSCLC). The new…
fda | 27 August 2011
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FDA approves Shire’s FIRAZYR for acute attacks of hereditary angioedema
Shire plc announced that the US Food and Drug Administration (FDA) has granted marketing approval for FIRAZYR (icatibant injection) for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. “Until now, HA…
fda | 25 August 2011
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FDA approves Zelboraf for treatment of BRAF mutation-positive metastatic melanoma
Roche announced that the US Food and Drug Administration (FDA) approved Zelboraf (vemurafenib) for the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma, as determined by an FDA-approved test. The FDA today also approved th…
fda | 17 August 2011
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Abbott receives FDA approval for Lupron Depot-PED for treatment of CPP
Two new strengths in a three-month formulation expand Lupron Depot-PED dosing options for children with CPP.
fda | 17 August 2011
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Watson's rosuvastatin zinc tablets receive tentative FDA approval
Watson Pharmaceuticals Inc announced that its subsidiary, Watson Laboratories Inc, has received tentative approval from the United States Food and Drug Administration (FDA) for its rosuvastatin zinc 5, 10, 20 and 40 mg tablets. Watson's rosuvastatin …
fda | 10 August 2011
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Furiex confirms Takeda's resubmissions of alogliptin NDAs to US FDA
Furiex Pharmaceuticals Inc confirmed that Takeda Pharmaceutical Company Limited has resubmitted two new drug applications (NDAs) for alogliptin to the US Food and Drug Administration (FDA). One application is for marketing approval of alogliptin, and…
fda | 27 July 2011
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FDA makes recommendation on investigational compound dapagliflozin
Bristol-Myers Squibb company and AstraZeneca reported the outcome of the US Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee meeting on the New Drug Application for the investigational compound dapagliflozin.…
fda | 20 July 2011
