Instrumentation Laboratory Receives FDA Clearance To Expand The Intended Use Of HemosIL(R) D-Dimer Assay (Medical News Today)
Instrumentation Laboratory (IL) announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance to expand the intended use for the HemosIL D-Dimer assay to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonar

Chelsea's Droxidopa receives US FDA Fast Track status for NOH (PharmaBiz)
US Food and Drug Administration (FDA) has granted Fast Track designation to Chelsea Therapeutics International's Droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension (NOH).

Alquest Support Yields FDA Approvals for Biotest Medical Diagnostics GmbH (Centre Daily Times)
Alquest, Inc. - the leading contract research organization (CRO) specialized in medical and diagnostic devices - recently helped its client, Biotest Medical Diagnostics GmbH, earn BLA (biologics license application) approvals through the Office of Blood Research and Review in the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration (FDA).