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13 HOURS AGO - Yahoo! News

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Studies criticize U.S. medical device approval process

By Andrew M. Seaman NEW YORK (Reuters Health) - Information on the safety and effectiveness of medical devices before and after they are cleared by U.S. health regulators can be improved, according to two new studies. One study found many U.S. Food and Drug Administration (FDA)-cleared medical devices meant to be implanted in the body were not backed by publicly ...

Tags: Studies criticize U.S. medical device approval process,  Food And Drug Administration Latest News

SEP 29, 2014 - Fox News

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FDA says asthma drug Xolair raises risk of heart, brain problems

The asthma drug Xolair is associated with a higher risk of heart attack, mini-stroke, chest pain and blood clots in the lungs and veins, among other problems, though the extent of increased risk is unclear, the U.S. Food and Drug Administration said on Friday.

Tags: FDA says asthma drug Xolair raises risk of heart, brain problems,  Food And Drug Administration Latest News

SEP 27, 2014 - Yahoo! News

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Bristol immunotherapy gets six month U.S. FDA review for melanoma

(Reuters) - The U.S. Food and Drug Administration has granted a six-month, priority review to Bristol-Myers Squibb Co's application for immuno-oncology drug Opdivo as a treatment for previously treated melanoma, the company said on Friday. The FDA decision is due by March 30, 2015. Bristol said European regulators have also agreed to an accelerated review of the drug as a ...

Tags: Bristol immunotherapy gets six month U.S. FDA review for melanoma,  Food And Drug Administration Latest News

SEP 27, 2014 - Yahoo! News

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Alimera, pSivida eye implant finally wins U.S. approval

By Vidya L Nathan and Anjali Rao Koppala (Reuters) - Alimera Sciences Inc and pSivida Corp said the U.S. Food and Drug Administration approved their vision-loss treatment Iluvien, following three rejections. Alimera's shares jumped about 16 percent to $5.95, while pSivida rose about 10.5 percent to $4.73 in extended trading. Iluvien will treat a condition known as diabetic macular edema ...

Tags: Alimera, pSivida eye implant finally wins U.S. approval,  Food And Drug Administration Latest News

SEP 26, 2014 - Yahoo! News

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Alimera's eye implant Iluvien wins FDA approval

(Reuters) - The Food and Drug Administration has approved Alimera Sciences Inc's and pSivida Corp's vision-loss treatment Iluvien after three rejections. The FDA approved Iluvien to treat a condition known as diabetic macular edema (DME), a swelling on the back of the retina that in the most severe cases can lead to blindness. Iluvien is an injectable implant. The treatment ...

Tags: Alimera's eye implant Iluvien wins FDA approval,  Food And Drug Administration Latest News