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Biomarin Files New Drug Application with US FDA for its PEG-PAL Drug
Biomarin Pharmaceutical announced that it has filed an investigational new drug application with the US Food and Drug Administration for its PEG-PAL d...

Proposed Sunscreen Rule Gets Extended Comment Period from FDA
The Food and Drug Administration announced that it will be extending the comment period on the agency's proposed sunscreen regulation to Dec. 26, 2007...

FDA Approves Zyrtec for Nonprescription Use in Adults and Children
The U.S. Food and Drug Administration has approved tablet, chewable tablet, and syrup formulations of Zyrtec (cetirizine HCl) for nonprescription use....

Nexavar Drug Therapy For Liver Cancer Gets FDA Approval
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New D...

Roche's ACTEMRA for the Treatment of Rheumatoid Arthritis to be Approved by FDA
Roche announced the submission of a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval to market ACTE...

Advanced Test for Monitoring Metastatic Colorectal Cancer Okayed by FDA
Veridex announced that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for the CellSearch System to be used as an aid in...

Roche's ACTEMRA for the Treatment of Rheumatoid Arthritis Awaits FDA Approval
Roche announced the submission of a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval to market ACTE...

Anoto Group’s Digital Pen and Paper Technology Gains Global Market Attention in Clinical Trials
22nd Annual DIA Presenter Dr. Massimo Raineri, PhD of Actelion Pharmaceuticals Ltd. Illustrates how Anoto Digital Pen and Paper Technology improves cl...

FDA Adds Boxed Warning for Heart Attacks to Anti-Diabetes Drug Avandia
The U.S. Food and Drug Administration announced today that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agre...

FDA Approves Cardiogenesis' PEARL 5.0 Robotic Hand Piece
Cardiogenesis Corporation , developer of surgical products for transmyocardial revascularization (TMR) today announced that the U.S. Food and Drug Adm...

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