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FDA
Scott Piergrossi, president of creative at Brand Institute, on the BioNTX "Inside Innovation" podcast. "Imagine creating a new English word that doesn't sound like or look like another English word," he said of the drug naming challenge. [Screenshot: "BioNTX Presents: Inside Innovation," via YouTube]
The Last Word: Pharma Is the ‘Only Product in the World’ That Needs Government Approval of Its Name, Brand Institute Exec Says
by Quincy Preston | Mar 26, 2026
A new BioNTX podcast digs into the regulatory gauntlet behind drug naming — and why biotech startups shouldn't wait to think about it.
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.
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![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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Photos: Epiminder
With U.S. HQ in Dallas, Epiminder Gets FDA Authorization for Implantable Monitor for Epilepsy Patients
by Lance Murray | Apr 23, 2025
"As the first and only implantable continuous EEG monitor approved in the U.S., Minder can provide health care professionals and their patients with more accurate and timely diagnoses, enhanced therapeutic drug monitoring, and can better inform decisions on non-drug treatments like surgery," said Epiminder CEO Rohan Hoare.
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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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Trinity Hunt Partners Make Majority Investment in Centricity Research
by Lance Murray | Jun 5, 2023
Dallas-based Trinity Hunt Partners announced a majority investment in Centricity Research, a clinical research services provider specializing in conducting Phase I-IV clinical trials across more than 40 therapeutic areas.
The amount of the investment was not disclosed.
“We are confident that Trinity Hunt’s expertise in partnering with growing healthcare services companies and its shared commitment to providing an empowering team environment will help us drive innovation and make significant strides as we continue to expand,” Centricity President Dr....
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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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John Timberlake, president and CEO, Berkshire Biomedical [Dallas Innovates; Image Sources: Berkshire Biomedical]
Dallas’ Berkshire Biomedical Gets NIH Research Grant for Home Methadone Dispensing System
by David Seeley | Aug 2, 2022
Berkshire's COPA System delivers automated at-home methadone doses to treat people with opioid use disorder. The computerized device offers biometric screening and real-time remote monitoring as it "accurately and securely" dispenses the medication. This can help patients avoid having to travel to clinics and wait in line for their treatment—often every single day.
"These are people who want to get over their addiction," says president and CEO John Timberlake, who believes COPA can "help these patients maintain their jobs and get back into society."
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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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