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Articles tagged with: FDA

GSK Arzerra Approved (NYSE:GSK)
10/27/2009 – 10:40 am PDT | Comments Off
GSK Arzerra Approved (NYSE:GSK)

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 | Comments Off
Amgen’s Plan for Denosumab (NASDAQ:AMGN)

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 | Comments Off
Amgen faces FDA delays (NASDAQ:AMGN)

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 | Comments Off
AstraZeneca’s Crestor Approved (NYSE:AZN)

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 | Comments Off
Acorda Gains Momentum (NASDAQ:ACOR)

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 | Comments Off
FDA approves Acorda’s MS drug (NASDAQ:ACOR)

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 | Comments Off
Acorda shares sink (NASDAQ:ACOR)

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 | Comments Off
Savient Pharma rises high (NASDAQ:SVNT)

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.

Acorda’s New Drug (NASDAQ:ACOR)
10/08/2009 – 9:30 am PDT | Comments Off
Acorda’s New Drug (NASDAQ:ACOR)

Acorda Therapeutics is very excited and waiting anxiously for the review of their new drug Amaya by the Food and Drug Administration advisory committee. Acorda’s new Amaya drug is targeted for the treatment of multiple …

Genzyme Receives FDA Letter (NASDAQ:GENZ)
10/07/2009 – 9:00 am PDT | Comments Off
Genzyme Receives FDA Letter (NASDAQ:GENZ)

Genzyme Corporation has announced that they have received a complete response letter from the Food and Drug Administration about the company’s supplemental New Drug Application for Clolar in patients suffering from acute myeloid leukemia or …