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Articles tagged with: FDA

GSK Arzerra Approved (NYSE:GSK)
10/27/2009 – 10:40 am PDT | No Comment

On Monday morning, the Food and Drug Administration panel approved Arzerra, a leukemia treatment that will be marketed and commercialized by GlaxoSmithKline Plc (ADR) (NYSE:GSK).

Amgen’s Plan for Denosumab (NASDAQ:AMGN)
10/23/2009 – 9:51 am PDT | No Comment

On Thursday, Amgen, Inc. (NASDAQ:AMGN) have opened up about the new plans about how the company will actually handle the request for the new information asked by the Food and Drug Administration panel.

Amgen faces FDA delays (NASDAQ:AMGN)
10/20/2009 – 8:00 am PDT | No Comment

On Monday morning Amgen Inc made an announcement that the Food and Drug Administration has issued them a Complete Response letter for the Biologic License Applications (BLA) for their new bone drug Denosumab (Prolia) for …

AstraZeneca’s Crestor Approved (NYSE:AZN)
10/19/2009 – 7:00 am PDT | No Comment

It was a good closing day for AstraZeneca as they announced that the Food and Drug Administration has approved Crestor (rosuvastatin calcium) for use in pediatric patients suffering from heterozygous familial hypercholesterolemia (HeFH).

Acorda Gains Momentum (NASDAQ:ACOR)
10/16/2009 – 10:09 am PDT | No Comment

Acorda Therapeutics had a not so very good Wednesday morning with NASDAQ halting their trading on the stock market as the review by the Food and Drug Administration panel was due.

FDA approves Acorda’s MS drug (NASDAQ:ACOR)
10/16/2009 – 5:30 am PDT | No Comment

It was a bad news for Acorda Therapeutics when they heard the news that NASDAQ has halted their trading and shares of Acorda Therapeutics were 18 percent down on the stock market.

Acorda shares sink (NASDAQ:ACOR)
10/12/2009 – 9:33 am PDT | No Comment

It was a not a good closing day for Acorda Therapeutics when shares of its company went down drastically after the negative review by the Food and Drug Administration panel.

Savient Pharma rises high (NASDAQ:SVNT)
10/12/2009 – 8:30 am PDT | No Comment

On a late Friday afternoon, shares of Savient Pharmaceuticals bounced back as analysts for Oppenheimer and Co. raised his views on Savient Pharmaceuticals and its new chronic gout drug candidate Krystexxa.