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EDAP Submits 510 Filing to U.S. FDA for Sonolith I-Sys
EDAP announced that it has filed a 510(k) marketing application with the U.S. Food and Drug Administration (FDA) for its newly designed, high-end Sono...

IMRIS receives FDA clearance for 3 Tesla IMRISneuro
IMRIS announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's 3 Tesla IMRISneuro for sale in the U.S. IMRISneuro is now a...

Neuralstem Files FDA Application for First ALS Stem Cell Trial
Neuralstem has announced this morning that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA...

FDA Submission of Isosulfan Blue Injection ANDA
Synerx Pharma, LLC announced the submission to the FDA of Isosulfan Blue Injection (generic equivalent to Lymphazurin, Covidien (formerly US Surgical)...

VETORYL(Trilostane) Receives FDA Approval
Dechra Veterinary Products announced that the company has received FDA approval to market VETORYL Capsules.VETORYL Capsules contain the drug trilosta...

FDA Education Program Wins Award
"FDA Patient Safety News," the FDA's monthly video series for health care professionals, has won the Cheers Award from the Institute for Safe Medicati...

FDA Requires New Safety Measures for Oral Sodium Phosphate Products to Reduce Risk of Acute Kidney Injury
Today, the U.S. Food and Drug Administration announced that it will add a Boxed Warning to the prescription oral sodium phosphate products Visicol and...

ev3 Receives FDA Clearance to Market EverCross and NanoCross Peripheral Angioplasty Balloons
ev3, a global endovascular device company, announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market it...

Sunquest Receives FDA Clearance for Transfusion Management Solution
Sunquest Information Systems, pioneer in laboratory and diagnostic information systems, announced that it received clearance from the U.S. Food and Dr...

Roche and FDA Agree on Pathway Towards U.S. Approval of ACTEMRA
Roche announced that the U.S. Food and Drug Administration (FDA) has provided further guidance on the requirements for the Biologics License Applicati...

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