Robert Hilton, Ph.D on Food and Drug Administration (FDA)

New Tool From EPA, FDA, and USDA Guides Developers of Genetically Modified Microorganisms Through Regulatory Landscape

On October 2, 2024, the U.S. Department of Agriculture (USDA), U.S. Environmental Protection Agency (EPA), and U.S. Food and Drug Administration (FDA) released a new web-based interactive tool on the Unified Website for...more

11/14/2024 / Biotechnology , DEA , Environmental Protection Agency (EPA) , Food and Drug Administration (FDA) , GMO , USDA

FDA Approves Qalsody™ for Treatment of ALS

On April 25th, 2023, the U.S. Food and Drug Administration (FDA) approved QalsodyTM (tofersen) for the treatment of amyotrophic lateral sclerosis (ALS) associated with a mutation in the superoxide dismutase 1 (SOD1) gene...more

5/31/2023 / FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry

FDA Grants Breakthrough Status to Dthera Sciences' Alzheimer's Therapeutic

On August 23, 2018, Dthera Sciences announced that the Food and Drug Administration granted Breakthrough Therapy designation to its Alzheimer’s disease therapeutic device. According to the FDA, Breakthrough Therapy...more

9/4/2018 / Breakthrough Therapy Designation , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry

First Prosthetic Iris Approved

On May 30, 2018, the Food and Drug Administration announced the approval of the CustomFlex Artificial Iris. According to the FDA, this is the first approved artificial iris. The approval was granted to Clinical Research...more

6/13/2018 / FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Premarket Approval Applications

FDA Approves NorthStar's Tc-99m Generator

The Food and Drug Administration recently announced approval of the RadioGenix™ System, a technetium 99m (Tc-99m) generator. The RadioGenix™ System is developed by NorthStar Medical Radioisotopes, LLC, a nuclear medicine...more

3/3/2018 / FDA Approval , Food and Drug Administration (FDA) , Infectious Diseases , Medical Devices

Bayer Receives Accelerated Approval for Aliqopa

On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Aliqopa to Bayer Healthcare Pharmaceuticals, Inc., for the treatment of relapsed follicular lymphoma. The FDA granted Aliqopa...more

10/10/2017 / Bayer , Cancer , Fast Track Process , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

Embrace™ Neonatal MRI Device Gains FDA Clearance

On July 20, 2017, the Food and Drug Administration announced the clearance of “the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU)” to...more

8/12/2017 / 510(k) RTA , Diagnostic Tests , Food and Drug Administration (FDA) , Medical Devices , Premarket Approval Applications

Supreme Court Grants Certiorari in Amgen v. Sandoz

On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more

FDA Approves the First Insulin Pump and Glucose Monitoring System for Children

West Chester, Pennsylvania-based Animas Corporation recently announced FDA approval for the use of the Animas®Vibe® Insulin Pump and Continuous Glucose Monitoring (CGM) System for children and adolescents, ages two to...more

2/2/2016 / Food and Drug Administration (FDA) , Medical Devices , Pediatrics

Robert Hilton, Ph.D

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