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FDA Wants Another Retaane Study

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FDA tells Alcon it wants another clinical study of Retaane for wet age-related macular degeneration.

FDA Clears Instrumentation Lab 510 (k)

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FDA clears an Instrumentation Laboratory 510(k) for HemosIL RecombiPlasTin 2 G, a prothrombin time reagent.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites F.H.G. Corp, Kunshan Chemical and Pharmaceutical, and Leiner Health Products.

Drug Safety Office Gets Deputy from NIH

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CDERs Office of Surveillance and Epidemiology hires Henry Skip Francis from the NIH Fogarty International Center as its deputy dir...

Supreme Court to Hear Rezulin Patent Case

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The U.S. Supreme Court agrees to hear Pfizers challenge to an appeals court decision that allowed a Michigan suit against its Rezu...

NexMed Files NDA on Alprostadil Cream

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NexMed submits an NDA for its topically applied alprostadil cream, indicated for treating erectile dysfunction.

Fast-Track for Progens Primary Liver Cancer Drug

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FDA grants fast-track status to Progen Pharmaceuticals for its investigational drug for preventing tumor recurrence after curative...

Merck Ends HIV Vaccine Tests

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Merck ends a Phase 2 trial of its V520 investigational HIV vaccine because it was ineffective.

Axcil and Desirin Recalled

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TWC Global recalls Axcil and Desirin dietary supplements because they contain sildenafil and two of its analogs.

Encysive Proceeding with New Phase 3 Thelin Trial

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Encysive Pharmaceuticals says it will conduct the additional Phase 3 trial of its Thelin that FDA wants to demonstrate the drugs e...