BioMedNewsBreaks Archive - Page 6 of 240

WednesdaySep 24, 2025 11:14 am

BioMedNewsBreaks — NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Receives FDA Approval of Suitability Petition for Preservative-Free Ketamine Product

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration has granted its Suitability Petition for KETAFREE(TM), a planned single-patient, preservative-free ketamine product. Unlike current ketamine offerings in multi-dose vials containing the toxic preservative Benzethonium Chloride, KETAFREE(TM) is designed to eliminate such additives. The approval enables immediate re-filing of the Company’s Abbreviated New Drug Application. NRx noted the product supports federal priorities of re-shoring sterile drug manufacturing and removing harmful preservatives, with the ketamine market estimated at $750 million. The Company is also advancing NRX-100, a non-generic ketamine formulation under development for suicidal depression…

WednesdaySep 24, 2025 9:40 am

BioMedNewsBreaks – Oncotelic Therapeutics, Inc. (OTCQB: OTLC) Joint Venture Sapu Nano Receives Approval to Begin Phase 1 Trial of Injectable Everolimus for Breast Cancer

Oncotelic Therapeutics (OTCQB: OTLC) announced that its joint venture through GMP Biotechnology Limited, Sapu Nano, has received approval from Australia’s Human Research Ethics Committee to begin enrolling patients in a Phase 1 human clinical trial of Sapu003, an injectable form of Everolimus for breast cancer. Everolimus, marketed as Afinitor(R), is FDA-approved in oral form but has limited absorption of about 10%. Using Sapu Nano’s Deciparticle(TM) technology, Sapu003 is delivered intravenously, allowing full drug absorption into the bloodstream. Preclinical data suggest this approach could improve efficacy over the oral version. The trial will determine optimal dosing for future studies, including a…

TuesdaySep 23, 2025 12:42 pm

BioMedNewsBreaks — Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) Integrates Radiation Dose Personalization into IzoView Breast CT System

Izotropic (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3), a medical device company focused on advanced breast cancer imaging technologies, announced the integration of a patent-pending radiation dose personalization feature into its IzoView Breast CT Imaging System. The innovation uses a radiation-free optical pre-scan and proprietary software to calculate customized dosing for each patient’s breast size, streamlining exam setup and improving comfort. Developed using models from UC Davis Medical Center, the system positions IzoView as the first breast CT to offer real-time personalized dosing. With the global breast imaging market projected to grow to $8.69 billion by 2030, Izotropic is advancing IzoView…

TuesdaySep 23, 2025 11:35 am

BioMedNewsBreaks – NextPlat Corp (NASDAQ: NXPL, NXPLW) Advances Development of ClearMetrX 4.0 With AI-Enhanced Healthcare Analytics

NextPlat (NASDAQ: NXPL, NXPLW), a global consumer products and services company, announced its ClearMetrx subsidiary has entered late-stage development of ClearMetrX 4.0, the next generation of its proprietary healthcare data analytics and reporting software. Scheduled for internal rollout in Q4 2025 and commercialization in the first half of 2026, ClearMetrX 4.0 integrates AI-powered capabilities including revenue forecasting, predictive inventory management, anomaly detection, fraud prevention, audit support, and scenario modeling. The cloud-based platform is already in use across the Company’s pharmacies and client network, streamlining analytics for physicians, MSOs, 340B entities, and pharmacies. NextPlat said the upgrade reflects its commitment to…

TuesdaySep 23, 2025 11:05 am

BioMedNewsBreaks – Soligenix Inc. (NASDAQ: SNGX) Appoints Tomas J. Philipson, PhD as Strategic Advisor

Soligenix (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases, announced the appointment of Tomas J. Philipson, PhD as a Strategic Advisor. Dr. Philipson, an expert in U.S. economic and healthcare policy with extensive academic, business, and government experience, previously served as acting chairman of the White House Council of Economic Advisers and has advised FDA, CMS, and major healthcare initiatives. He currently serves as Managing Partner of MEDA Ventures and on several corporate boards. Soligenix CEO Christopher J. Schaber, PhD, said Philipson’s expertise and relationships will be instrumental as the company advances…

TuesdaySep 23, 2025 10:18 am

BioMedNewsBreaks — Fifty 1 Labs, Inc. (OTC: FITY) Engages PCAOB Auditor to Support Planned OTCQB Uplist

Fifty 1 Labs (OTC: FITY), a Nevada-based holding company focused on AI-driven drug repurposing and functional medicine, announced it has signed a letter of engagement with a Public Company Accounting Oversight Board registered auditing firm to conduct audits of its 2024 and 2025 financial statements. The audits mark a key step in the company’s plan to uplist to the OTCQB Venture Market, which requires strict reporting and governance standards. CEO Paul Arora said the engagement underscores Fifty 1 Labs’ commitment to transparency and corporate governance, while laying the groundwork to strengthen investor confidence as it advances biotech and wellness initiatives.…

MondaySep 22, 2025 9:30 am

BioMedNewsBreaks – Oncotelic Therapeutics, Inc. (OTCQB: OTLC) CEO Featured on IBN’s BioMedWire Podcast

Oncotelic Therapeutics (OTCQB: OTLC), a clinical-stage biopharmaceutical company developing transformative oncology and immunotherapy treatments, is featured in the latest episode of IBN’s BioMedWire Podcast. Chairman and CEO Dr. Vuong Trieu discussed the company’s mission to treat cancer and rare diseases, emphasizing Oncotelic’s expertise in tumor microenvironments, regulatory pathways, and intellectual property strategies. He noted that investors should watch for multiple clinical and regulatory milestones over the next 12 months, including IND approvals, expanded indications, and partnership announcements. To view the full press release, visit https://ibn.fm/QbKCl About Oncotelic Therapeutics Inc. Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on the development…

MondaySep 22, 2025 9:10 am

BioMedNewsBreaks – HeartBeam Inc.’s (NASDAQ: BEAT) First-of-Its-Kind Cable-Free ECG Offers Multi-Angle Signal Capture

As clinicians increasingly recognize the value of accurate at-home electrocardiogram (“ECG”) capture, HeartBeam (NASDAQ: BEAT) is positioned at the forefront of this transformation. The company’s FDA-cleared HeartBeam System is the first cable-free ECG device that captures the heart’s signals from three distinct directions and is designed to be a groundbreaking solution for at-home detection and monitoring of arrhythmias. “HeartBeam’s proprietary system allows for high-fidelity measurements without the complexity of conventional equipment. Unlike standard devices that capture electrical signals from limited perspectives, HeartBeam’s patented approach records from three distinct angles, enabling a more complete view of the heart’s electrical activity. This…

FridaySep 19, 2025 1:55 pm

BioMedNewsBreaks — Nutriband Inc. (NASDAQ: NTRB) Eyes Clear Development Pathway for AVERSA(TM) Technology

Nutriband (NASDAQ: NTRB) is a transdermal pharmaceutical developer that has secured crucial FDA engagement for its lead abuse-deterrent technology. “Nutriband’s FDA Type C Meeting approval for AVERSA(TM) Fentanyl signals agency recognition of the product’s potential to address critical unmet medical needs. The Sept. 18 meeting with the Division of Anesthesiology, Addiction Medicine, and Pain Medicine focuses on Chemistry, Manufacturing, and Controls (‘CMC’) plans spanning the entire development and commercialization timeline,” reads a recent article. “This milestone addresses the complete development arc from IND submission through 505(b)(2) NDA approval. The 505(b)(2) pathway allows Nutriband to leverage existing fentanyl safety data while focusing…

FridaySep 19, 2025 11:00 am

BioMedNewsBreaks — Soligenix Inc. (NASDAQ: SNGX) Leveraging Positive Clinical Data to Shape Pivotal SGX942 Trial

Soligenix (NASDAQ: SNGX) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases with unmet medical need. The company’s SGX942 is a novel therapeutic aimed at alleviating oral mucositis, a debilitating side effect of cancer therapy with no FDA-approved treatment. “Severe oral mucositis (‘SOM’) often necessitates hospitalization, opioid pain management and feeding tube placement, lowering quality of life substantially. Because of these risks, effective treatment or prevention is critical to ensuring cancer therapies remain on schedule and patients maintain nutrition and comfort,” reads a recent article. In response, the company is advancing a promising candidate,…

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BioMedNewsBreaks

BioMedNewsBreaks — NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Receives FDA Approval of Suitability Petition for Preservative-Free Ketamine Product

BioMedNewsBreaks – Oncotelic Therapeutics, Inc. (OTCQB: OTLC) Joint Venture Sapu Nano Receives Approval to Begin Phase 1 Trial of Injectable Everolimus for Breast Cancer

BioMedNewsBreaks — Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF) (FSE: 1R3) Integrates Radiation Dose Personalization into IzoView Breast CT System

BioMedNewsBreaks – NextPlat Corp (NASDAQ: NXPL, NXPLW) Advances Development of ClearMetrX 4.0 With AI-Enhanced Healthcare Analytics

BioMedNewsBreaks – Soligenix Inc. (NASDAQ: SNGX) Appoints Tomas J. Philipson, PhD as Strategic Advisor

BioMedNewsBreaks — Fifty 1 Labs, Inc. (OTC: FITY) Engages PCAOB Auditor to Support Planned OTCQB Uplist

BioMedNewsBreaks – Oncotelic Therapeutics, Inc. (OTCQB: OTLC) CEO Featured on IBN’s BioMedWire Podcast

BioMedNewsBreaks – HeartBeam Inc.’s (NASDAQ: BEAT) First-of-Its-Kind Cable-Free ECG Offers Multi-Angle Signal Capture

BioMedNewsBreaks — Nutriband Inc. (NASDAQ: NTRB) Eyes Clear Development Pathway for AVERSA(TM) Technology

BioMedNewsBreaks — Soligenix Inc. (NASDAQ: SNGX) Leveraging Positive Clinical Data to Shape Pivotal SGX942 Trial

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