U.S. Food and Drug Administration

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."
Nanoscope Therapeutics Strengthens Clinical, Regulatory Expertise with Appointment of Chief Medical Officer
by | Sep 22, 2023
Samuel Barone, M.D., is a former Federal Drug Administration official and leader in the pharmaceutical space.
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.
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.

Frisco Startup Lands First U.S. Authorization for COVID-19 Breathalyzer Test

by | Apr 18, 2022
Frisco-based InspectIR received the FDA emergency use authorization on Friday for its breathalyzer test, which tests for organic compounds associated with COVID-19 in a person's breath. According to a study, the tests are more effective than the rapid antigen tests available for free from the U.S. government.
Spectral MD burn
Spectral MD Gets $27M to Advance Trials of AI-Powered Wound, Burn Care Device
by | Jul 24, 2019
Spectral's device uses real-time data and artificial intelligence to help look beneath the skin's surface and assess wound and burn damage, which can help doctors improve treatments and outcomes — as well as be a tool in the response to mass burn casualties in a national emergency.
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.