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Bluegrass Vascular De Novo for Catheter System

[ Price : $8.95]

FDA grants Bluegrass Vascular Technologies a de novo marketing order for its Surfacer Inside-Out Access Catheter System.

Epizyme sNDA for Tazverik in Follicular Lymphoma

[ Price : $8.95]

FDA accepts for review an Epizyme supplemental NDA seeking accelerated approval for Tazverik (tazemetostat for certain patients wi...

FibroGen NDA for Chronic Kidney Disease Anemia

[ Price : $8.95]

FDA accepts for review a FibroGen NDA for roxadustat for treating anemia associated with chronic kidney disease.

FDA Monitoring for Shortages Under Virus Plan

[ Price : $8.95]

FDA says it expects the coronavirus outbreak will lead to medical product supply chain disruptions as it reaches out to manufactur...

28 No Longer Marketed ANDAs Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of 28 ANDAs from multiple applicants.

Man Sentenced to 7 Years Over Unapproved Drug

[ Price : $8.95]

Florida federal judge Paul G. Byron sentences Barry Clint Wright (Monroe, NC) to seven years in federal prison for introducing an ...

FDA Justifies FY 2021 $6.2 Billion Budget Request

[ Price : $8.95]

FDA sends Congress its justification for a $6.2 billion FY 2021 budget request.

Guide on Peripheral Vascular Atherectomy Device PMAs

[ Price : $8.95]

Federal Register notice: FDA posts a final guidance entitled Peripheral Vascular Atherectomy Devices Premarket Notification Submi...

FDA Seeks Nonvoting Patient Engagement Panel Members

[ Price : $8.95]

Federal Register notice: FDA seeks industry organizations interested in participating in selecting nonvoting industry representati...

Foreign Free-Riding on U.S. Drug Investment Up: Report

[ Price : $8.95]

The White House Council of Economic Advisers says the U.S. has paid more than its fair share for drug development and innovation b...