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Allos Therapeutics Announces FDA Accepts Pralatrexate NDA for Filing and Grants the Application Priority Review Status
Allos Therapeutics, 05/27/09

Allos Therapeutics, Inc. announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application for pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. The Company also announced that the FDA has granted the NDA priority review status and established a Prescription Drug User Fee Act date of September 2009 for a decision regarding approval of the NDA. Priority review designation is assigned to drugs that have the potential to provide a significant improvement compared to marketed products or provide a safe and effective therapy where no satisfactory therapy exists.

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FDA Approves Gardasil to Prevent Genital Warts in Males. Agency Also Approves Bivalent HPV Vaccine for Girls, Young Women
American Family Physician, 10/22/09

Novartis receives FDA approval for Valturna®, a single-pill combination of valsartan and aliskiren, to treat high blood pressure
Novartis, 09/18/09

Salix Receives FDA Marketing Approval for Metozolv
Salix Pharmaceuticals, 09/10/09

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Salix Receives FDA Marketing Approval for Metozolv
Salix Pharmaceuticals, 09/10/09

FDA Grants Emergency Use Authorization of the Prodesse ProFlu-ST(TM)
Gen-Probe, 11/02/09

Covidien Receives FDA Approval for Oral Transmucosal Fentanyl Citrate Product
Covidien, 11/05/09

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