U.S. Food and Drug Administration

3 UT Dallas Professors Win 2024 Cerami Award for Bioelectronic Medicine Research

by | Feb 6, 2025
The honors to UTD's Michael Kilgard, PhD, Robert Rennaker, PhD, and Seth Hays, PhD, are the first time the award will go to scientists who have made significant strides in translational bioelectronic medicine research.
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North Texas’ Caris Life Sciences Gets FDA Approval for its ‘MI Cancer Seek’ Companion Diagnostic Test
by | Nov 6, 2024
Caris said MI Cancer Seek will be used as a companion diagnostic to identify cancer patients who may benefit from treatment with targeted therapies.
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Dallas’ Articulate Labs Tapped by Medical Device Innovation Consortium for Advanced Tech Initiative
by | Aug 12, 2024
MDIC is piloting the AMCH program, with support from the U.S. Food and Drug Administration, to help encourage the medical device industry to adopt advanced technology not just during device production but across the total product life cycle.
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Revolution Gets FDA Nod for Up to 100% Recycled Stretch Plastic Food Packaging Material
by | Oct 26, 2023
Revolution—which is based in Little Rock with corporate offices in Flower Mound and a manufacturing facility in Mesquite—says the introduction of clear food grade LLDPE PCR "will boost innovations in recycled packaging."
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Reata CEO Warren Huff

Plano’s Reata Pharmaceuticals Launches First Product: The Rare-Disease Drug Skylarys

by | Jun 29, 2023
Reata cleared the final FDA hurdle to get its rare-disease drug Skylarys on the market, the company announced Tuesday. The drug is now available to U.S. patients who've been diagnosed with Friedreich’s ataxia—a genetic disorder that can cause progressive damage to the nervous system. The announcement marks Reata’s first drug approval since the company was founded in 2002, according to the Dallas Morning News.
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On Rare Disease Day, Plano Biotech Reata Pharmaceuticals Gets Its First FDA Approval
by | Mar 2, 2023
The FDA approval is not only a first for Reata's treatment of ultra-rare disease Friedreich's Ataxia. It's a first in the company's history, reports FiercePharma. On the news, Reata’s stock skyrocketed nearly 200% Wednesday, according to the Dallas Morning News, which cited an estimate that the drug will create a revenue stream in excess of $1 billion.
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Nanoscope Therapeutics Names New Vice President of Quality
by | Jan 11, 2023

Nanoscope Therapeutics Inc., a Dallas-based clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, has appointed Massoud Motamed, Ph.D., as vice president of quality.

Motamed brings nearly a decade of CGMP quality and compliance experience, including extensive experience in manufacturing and regulatory review of gene therapy products....

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Discovery: UTA Team Creating Water Modeling Tool for Trinity River; UTSW Finds How ‘Bad Cholesterol’ Enters Artery Walls

by | May 3, 2019
You'll also find out about how the FDA has granted Breakthrough Device status to a new Caris Life Sciences cancer test in this roundup of research and development activity in North Texas.
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