Year: 2025

FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review. Assigned GDUFA goal date is July 29, 2026. NRx has applied to FDA for use of KETAFREE™ as a proprietary product name, which is subject to review. KETAFREE™ is the first preservative-free ketamine formulation that does not include potentially toxic preservatives used in current multidose presentations of ketamine. Current worldwide generic ketamine market is estimated at $750 million per year. NRx has manufactured initial registration lots of KETAFREE™ and is prepared to scale manufacturing to 1 million vials per month. NRx is awaiting a response to its Citizen Petition filed in August with the FDA seeking the removal of Benzethonium Chloride preservative from all forms of ketamine sold in the...

Strategic Roadmap Provides Further Insight into the Company’s Evolution, Pairing Digital Assets with Operating Cash Flow to Create Durable Shareholder Value WILMINGTON, Del., Dec. 02, 2025 (GLOBE NEWSWIRE) — Onfolio Holdings Inc. (Nasdaq: ONFO, ONFOW) (OTC: ONFOP) (the “Company” or “Onfolio”), a pioneer in pairing operating profits from digital businesses with the upside and staking yield from digital assets, published to its website a strategic roadmap titled, “Building a Modern Public Holding Company: Why Onfolio Is Pairing Digital Assets With Operating Cash Flow.” The strategic roadmap, found at onfolio.com/more-than-dat, offers further insight into the Company’s recently introduced strategy to create a truly “digital economy” public company that paired operating profits from digital businesses, with...

New FoodChannel.com features modern design and improved performance to elevate recipe discovery experience NEWPORT BEACH, Calif., Dec. 02, 2025 (GLOBE NEWSWIRE) — Amaze Holdings, Inc. (NYSE American: AMZE) (“Amaze”) a global leader in creator-powered commerce, today announced the official relaunch of The Food Channel®, unveiling a refreshed website that honors the brand’s rich culinary legacy while introducing a modernized platform experience for creators and fans. The redesigned FoodChannel.com features updated navigation, a streamlined layout, and enhanced performance to make discovering recipes, culinary inspiration, and food trends easier than ever. The new site provides a more visual, intuitive experience and sets the foundation for future interactive features and e-commerce integrations. “Relaunching The Food Channel website...

MELBOURNE, Australia and PALM BEACH, Fla., Dec. 02, 2025 (GLOBE NEWSWIRE) — CYIOS Corp. (OTC: CYIO), a diversified holding company focused on acquiring, building, and scaling high-growth businesses in the medical, technology, and innovation sectors, is pleased to announce the appointment of John O’Shea as its new Chief Executive Officer and Chairman of the Board. A serial entrepreneur, published author, and seasoned senior executive with more than 30 years of experience across finance, technology, education, and high-growth venture building, O’Shea steps into the role with a bold vision: to transform CYIOS into a modern, AI-enabled powerhouse positioned for long-term expansion through a strategic acquisition strategy within the medical sector and adding shareholder value. A Proven Leader With Multi-Sector SuccessJohn O’Shea...

Appointment reinforces clinical and translational depth as Ernexa advances its best-in-class iMSC cell therapy platform into first-in-human trials CAMBRIDGE, Mass., Dec. 02, 2025 (GLOBE NEWSWIRE) — Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, today announced the appointment of Dr. Ira S. Winer, M.D., Ph.D., FACOG, to its Scientific and Medical Advisory Board. Dr. Winer is a nationally recognized gynecologic oncologist and translational scientist. His expertise in women’s oncology, immunotherapy, and early-phase clinical development further strengthens Ernexa’s capabilities as it advances its proprietary induced mesenchymal stem cells (iMSC) platform and lead program, ERNA-101, toward key milestones, including first-in-human...

VANCOUVER, British Columbia, Dec. 02, 2025 (GLOBE NEWSWIRE) — Cannabix Technologies Inc. (CSE: BLO) (OTCID: BLOZF) (Frankfurt: 8CT) (the “Company or Cannabix”) developer of marijuana and alcohol breath devices is pleased to announce that it has entered into a second sales agreement for its BreathLogix unmanned alcohol screening technology with an existing European maritime shipping customer. Under this agreement, the Company will deliver an additional BreathLogix unit to enhance operational safety among crew members through pre-access breath alcohol testing. The BreathLogix system will be integrated with the cloud-based BreathLogix Connect platform, powered by Amazon Web Services, enabling real-time alerts, centralized data management, and seamless reporting. Additionally, the device will feature facial recognition technology for...

Veteran gastroenterologist and clinical development leader with deep expertise driving global Phase 2/3 programs across immunology, neurology, and gastrointestinal disease Carlsbad, CA, Dec. 02, 2025 (GLOBE NEWSWIRE) — Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a clinical-stage biopharmaceutical company advancing next-generation, once daily, oral PDE4 inhibitor prodrugs for patients with inflammatory and fibrotic diseases, today announced the appointment of James Izanec, MD, AGAF as Vice President, Clinical Development.Dr. Izanec is a physician–scientist with over two decades of clinical and drug development leadership spanning immunology, neuroscience, and gastroenterology. He brings extensive experience directing registrational Phase 2 and Phase 3 programs, shaping asset-level development strategies, and...

SHOUGUANG, China, Dec. 02, 2025 (GLOBE NEWSWIRE) — Gulf Resources, Inc. (“Gulf Resources,” “we,” or the “Company”) announced today that it received notification from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) that the Company has regained compliance with Nasdaq’s requirement under Listing Rule 5550(a)(2). The hearing before the Hearings Panel scheduled to take place on December 9, 2025, has been cancelled. The Company’s common stock will continue to trade on the Nasdaq Capital Market under the symbol GURE.  About Gulf Resources, Inc.Gulf Resources, Inc. operates through four wholly-owned subsidiaries, Shouguang City Haoyuan Chemical Company Limited (“SCHC”), Shouguang Yuxin Chemical Industry Co., Limited (“SYCI”), Daying County Haoyuan Chemical Company Limited (“DCHC”) and Shouguang Hengde Salt...

sNDA for treatment of sBCC with Ameluz®-PDT submitted to U.S. Food and Drug Administration (FDA) on November 28, 2025 First Phase 3 PDT study in patients with sBCC in the United States submitted to FDA Primary and key secondary endpoints met with high statistical significance (p

Experienced Corporate Finance and Technology/Digital-Asset Leader to Guide Board Strategy and Growth Initiatives AUSTIN, Texas, Dec. 02, 2025 (GLOBE NEWSWIRE) — Phunware, Inc. (“Phunware” or the “Company”) (NASDAQ: PHUN), the enterprise cloud platform for mobile that provides products, solutions, data, and services for brands to engage, manage and monetize global audiences, today announced that Elliot Han was appointed Chairperson of the Company’s Board of Directors and Chairperson of the Board’s Audit Committee, each effective October 2025. Mr. Han has served as a Class II non-employee Director on the Company’s Board since January 2024 and will continue to chair the Board’s Compensation Committee. Since February 2025, Mr. Han has served as Chief Investment Officer of C1 Fund Inc., a NYSE-listed closed-end investment company...