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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...

FDA Approves Nonprescription Zyrtec-D for Allergies
The Food and Drug Administration (FDA) has approved Zyrtec-D (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg), an allergy drug, for nonprescriptio...

FDA Clears Silver-Coated Breathing Tube for Marketing
The U.S. Food and Drug Administration today announced that it has cleared for marketing a breathing tube coated with a thin layer of silver. The coati...

FDA Strengthens Boxed Warnings, Approves Other Safety Labeling Changes for Erythropoiesis-Stimulating Agents (
The U.S. Food and Drug Administration today approved revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimu...

Oracle Fusion GRC Intelligence New Release Centralizes Risk and Compliance Information Across the Enterprise
Oracle announced the latest version of Oracle Fusion Governance Risk and Compliance (GRC) Intelligence. This release delivers expanded risk and compli...

FDA Clears for New Sprycel Product Labeling for Patients with Chronic-Phase CML
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has approved new labeling for SPRYCEL to include a lower recom...

FDA Gives 510(k) Clearance to Baxter's New Antimicrobial Intravascular Technology
Baxter Healthcare Corporation announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its V-Link Luer-activat...

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