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FDA
[Image: Black_Kira/istockphoto]
Lantern Pharma Preps 2026 Trial for Rare Pediatric Brain Cancer After FDA Guidance
by Quincy Preston | Oct 14, 2025
The North Texas biotech, which uses AI to accelerate cancer drug development, received FDA feedback to advance a new clinical study targeting a rare childhood brain tumor.
![Ben Dorks, CEO of Ideagen, said the SafetyStratus deal adds deep chemical management expertise to the UK company’s EHS platform, expanding its reach in life sciences, healthcare, energy, and manufacturing. [Photo: Ideagen]](https://s24806.pcdn.co/wp-content/uploads/2025/10/Ideagen-acquire-Plano-SafetyStratus-Ben-Dork-360x203.jpg)
by Quincy Preston |
Oct 2, 2025
Plano-based SafetyStratus, incubated at Cornell in 2011, expands Ideagen’s environmental, health, and safety platform with chemical management capabilities used by more than 500,000 people worldwide.
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by Quincy Preston |
Jul 15, 2025
North Texas' Nanoscope just filed an FDA bid for its gene-agnostic therapy. If approved, it could help restore sight for people with inherited blindness, and potentially millions more with other retinal diseases.
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by Glenn Hunter |
Apr 30, 2025
Dallas Innovates, in partnership with the Dallas Regional Chamber, once again is recognizing the most innovative leaders in AI in Dallas-Fort Worth. From visionaries and mavericks to transformers and academics, AI 75's class of 2025 are the AI pacesetters you need to know now.
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Highlander Health Co-Founders Amy Abernethy, M.D., Ph.D., and Brad Hirsch, M.D. [Photo: Business Wire]
Pegasus Park Speaker Series To Offer ‘Insights From the Frontlines of Health Policy’ by Former FDA Leaders
by David Seeley | Apr 10, 2025
Moderated by Highlander Health Co-Founder Brad Hirsch, next Wednesday's free public event will feature two former FDA commissioners and a former FDA acting chief information officer. The focus: "how the FDA has evolved across four presidential administrations."
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by David Seeley |
Dec 13, 2023
Based in Vancouver with a North Texas office in Frisco, Alpha Cognition said its novel oral tablet ALPHA-1062 is designed for the treatment of people with mild to moderate Alzheimer's disease. The company was honored at the recent BioNTX iC3 Summit as one of eight "Rising Stars."
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by David Seeley |
Dec 11, 2023
On Friday, the first CRISPR-based gene-editing therapy to win FDA approval was announced. CASGEVY holds "the potential of a functional cure" for sickle cell disease—and Medical City Children’s is one of only nine hospitals in the U.S. in its initial network of authorized treatment centers.
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by Quincy Preston |
Jul 18, 2023
Parker Health's cloud Health Management System is the first in the U.S. to build on the Fast Healthcare Interoperability Resources—or FHIR—standard to create an interoperable, affordable, and compliant cloud-based platform. The Parker Suite aims to unify patient-centric data, biometrics, diagnostic tools, patient outcomes, care delivery, practitioner engagement, and pharmaceuticals for the healthcare ecosystem.
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[Image: Myvector/iStockphoto]
Dallas’ MedCognetics Gets FDA Clearance for Its AI-Enabled Breast Cancer Screening Software
by David Seeley | Dec 20, 2022
The early-stage startup's QmTRIAGE software platform uses AI and machine learning to detect early breast cancers with a "high rate" of accuracy, MedCognetics says. The company has worked with UT Southwestern and UT Dallas to ensure its AI improves outcomes for "all ethnicities," at a time when racial disparities in AI have become a growing concern.
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by Kevin Cummings |
Oct 18, 2022
Dallas-based Nanoscope Therapeutics is accelerating the development of therapies that could restore sight in patients with the help of a publicly traded firm. The retinal degenerative diseases-focused biotech company announced a new gene therapy manufacturing partnership with contract research organization Charles River Laboratories International.
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by Dallas Innovates | Staff Report |
Oct 17, 2022
Today is the first day that over-the-counter hearing aids can be sold without a prescription. It’s a moment that Fort Worth-based Lucid Hearing has been eyeing for years.
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by Kevin Cummings |
Aug 9, 2022
“Opioids are diabolical, because they actually change the structure and function of your brain; they change the way your reward system works,” said Daniel Powell, CEO at Spark Biomedical.
Meet Powell and six other startup leaders.
Meet Powell and six other startup leaders.
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Illustration: paitoonpati/iStock
Follow the Money: Jacobs Lands Nearly $4B NASA Contract; Dallas’ ReCode Therapeutics Adds $120M to Series B Raise, and More
by Kevin Cummings | Jul 11, 2022
Plus, Enhabit Home Health Hits the NYSE, Irving Web3 Investor Raising Two New Funds, TPG leads $750M raise in clean energy firm; Coppell-based Neurolens raises $2.7M; Fort Worth's Jet Health raises $1M; Frisco edtech startup Meritize lands funding; Honeywell acquires Fort Worth nitrile glove maker Rhino Health USA; and more North Texas-related deals.
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by Kevin Cummings |
May 12, 2022
AyuVis, an immunotherapy startup, is set to get a $1.8 million Small Business Innovation Research grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The funding will support the pre-clinical research of its drug candidate to treat the second-leading cause of death in premature babies.
Founder Suchismita Acharya calls the timing "perfect."
Founder Suchismita Acharya calls the timing "perfect."
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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 David Seeley |
Aug 16, 2021
Stelfonta received FDA approval last November to treat dogs with non-metastatic, skin-based mast cell tumors (MCTs)—the most common malignant skin tumor in dogs. The injection is now available at vet clinics across the U.S., with an 88% "satisfactory experience" rate to date.
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