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U.S. Food and Drug Administration
David Halbert, founder, chairman, and CEO of Caris Life Sciences. [Photo: Caris Life Sciences]
North Texas’ Caris Life Sciences Gets FDA Approval for its ‘MI Cancer Seek’ Companion Diagnostic Test
by Lance Murray | 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.
by Lance Murray |
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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by Lance Murray |
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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by Lance Murray |
Sep 22, 2023
Samuel Barone, M.D., is a former Federal Drug Administration official and leader in the pharmaceutical space.
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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.
On Rare Disease Day, Plano Biotech Reata Pharmaceuticals Gets Its First FDA Approval
by Lance Murray | 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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by Lance Murray |
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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by Kevin Cummings |
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.
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by Lance Murray |
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.
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