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6 Current news of Actelion

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Actelion submits a NDA for macitentan for the treatment of patients with pulmonary arterial hypertension

23-Oct-2012

Actelion announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for macitentan (Opsumit®) for the treatment of patients with pulmonary arterial hypertension.Macitentan, a novel oral dual endothelin receptor antagonist, was ...

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Actelion receives FDA complete response letter for Zavesca (miglustat) for the treatment of Niemann-Pick type C disease

10-Mar-2010

Actelion Ltd announced that the company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for Zavesca® (miglustat) for the treatment of progressive neurological manifestations in adult and pediatric patients ...

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Zavesca receives positive vote from FDA for the treatment of Niemann-Pick type C disease

15-Jan-2010

Actelion Ltd announced that United States (US) Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted (10 yes to 3 no) in its final vote in question that the benefit/risk profile of Zavesca® (miglustat) supports its approval for the treatment of ...

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US Food and Drug Administration grants priority review for Actelion's miglustat in Niemann-Pick type C disease

19-Nov-2009

Actelion Ltd announced that a supplemental new drug application (sNDA) for an extension of indication for Zavesca® (miglustat) for the treatment of progressive neurological manifestations in adult and pediatric patients with Niemann-Pick type C disease (NP-C) has been accepted by the U.S. Food ...

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Tracleer receives label extension in the US

10-Aug-2009

Actelion Ltd announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) for Tracleer® (bosentan) to treat patients with mildly symptomatic WHO Functional Class II (FC II) pulmonary arterial hypertension (PAH). The U.S. FDA has ...

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Actelion's PGI2 receptor agonist demonstrates efficacy in pulmonary arterial hypertension patients

Morbidity-Mortality Phase III study to be initiated before year-end

20-Jul-2009

Actelion Ltd announced that positive data have been obtained in a Phase IIa study with its first-in-class orally active non-prostanoid PGI2 receptor agonist in pulmonary arterial hypertension (PAH) patients. In the 43 patient placebo-controlled double-blind study to assess efficacy, safety and ...

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