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51 MINS AGO - Yahoo! News

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FDA delays decision on key Alexion drug by 3 months

(Reuters) - Alexion Pharmaceuticals Inc said the U.S. Food and Drug Administration would delay by three months its decision on approving a key drug the company got through the acquisition of Synageva BioPharma Corp. European health regulators on Tuesday approved the drug, Kanuma, to treat lysosomal acid lipase deficiency (LAL-D), a progressive metabolic disease that often leads to liver failure, ...

Tags: FDA delays decision on key Alexion drug by 3 months,  Food And Drug Administration Latest News

2 HOURS AGO - Yahoo! News

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Novartis wins EU approval for multiple myeloma drug Farydak

Novartis AG said on Friday it received European Union approval for Farydak, a treatment for multiple myeloma that the company said gives new options for adult patients whose disease has progressed following standard therapy. Novartis received similar approval for Farydak from the U.S. Food and Drug Administration in February for treating multiple myeloma, a form of blood cancer that arises ...

Tags: Novartis wins EU approval for multiple myeloma drug Farydak,  Food And Drug Administration Latest News

3 HOURS AGO - Yahoo! News

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Cosmo gets U.S. approval for agent aimed at easing polyp removal

ZURICH (Reuters) - Cosmo Pharmaceuticals SA said on Friday that the U.S. Food and Drug Administration has given marketing authorization for SIC 8000, a product used in gastrointestinal tract procedures. Cosmo said SIC 8000 lifts mucous membranes in the esophagus, stomach, small and large intestines and other organs during removal of things such as polyps. Its shares, which had been ...

Tags: Cosmo gets U.S. approval for agent aimed at easing polyp removal,  Food And Drug Administration Latest News

4 HOURS AGO - Reuters

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Roche hemophilia drug wins fast-track FDA designation

ZURICH (Reuters) - Roche said on Friday it had won breakthrough therapy designation from the U.S. Food and Drug Administration for an experimental hemophilia medicine, aiming for a piece of the $11 billion hemophilia drug market.

Tags: Roche hemophilia drug wins fast-track FDA designation,  Food And Drug Administration Latest News

5 HOURS AGO - Yahoo! News

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AstraZeneca wins U.S. approval for longer use of blood thinner

U.S. regulators have approved a new dose of AstraZeneca's blood thinner Brilinta for longer-term use in patients with a history of heart attacks, boosting prospects for a drug the company thinks will eventually sell $3.5 billion a year. The green light from the U.S. Food and Drug Administration (FDA), announced late on Thursday, could theoretically more than double the number ...

Tags: AstraZeneca wins U.S. approval for longer use of blood thinner,  Food And Drug Administration Latest News