FridayAug 22, 2025 12:00 pm

NRx Pharmaceuticals Inc. (NASDAQ: NRXP) Seeks FDA Ban on Toxic Ketamine Preservative

NRx Pharmaceuticals has filed a Citizen Petition with the FDA to remove benzethonium chloride from ketamine products. The preservative has known toxicity and is no longer allowed in hand sanitizers or topical antiseptics. Ketamine is increasingly used off-label for treating suicidal depression and PTSD. The company argues repeated exposure to benzethonium chloride through IV use poses unnecessary health risks. NRx has submitted data showing its preservative-free ketamine maintains sterility and stability for three years. The company is pursuing FDA approval for both its preservative-free ketamine (“NRX-100”) and oral NMDA-targeting drug (“NRX-101”). NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, has…

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ThursdayAug 21, 2025 12:45 pm

Clene Inc. (NASDAQ: CLNN) Reports Q2 2025 Results as Company Prepares for NDA Submission and Extends Runway into 2026

Clene Inc. plans to submit a New Drug Application (“NDA”) for lead candidate CNM-Au8® in ALS by year-end 2025. FDA meetings scheduled in Q3 2025 will address ALS survival benefit data and MS development plans. Neurofilament light biomarker data analysis from the NIH-sponsored EAP program is expected in early Q4 2025. The company reported $7.3 million in cash and cash equivalents as of June 30, 2025, together with recent financing extending the company’s cash runway into Q1 2026. Clene (NASDAQ: CLNN) and its wholly owned subsidiary, Clene Nanomedicine Inc., a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and…

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WednesdayAug 20, 2025 11:15 am

Nutriband Inc. (NASDAQ: NTRB): When Regulatory Momentum Meets Leadership Continuity

FDA grants Type C Meeting for AVERSA(TM) Fentanyl to discuss Chemistry, Manufacturing, and Controls pathway from IND submission through NDA approval and commercialization CEO Gareth Sheridan temporarily steps aside to pursue Irish Presidential nomination while Chairman Serguei Melnik assumes interim CEO role during critical development phase Strategic partnership with Kindeva combines proven FDA-approved fentanyl patch technology with Nutriband's proprietary abuse-deterrent platform targeting $80-200 million peak U.S. market opportunity The pharmaceutical development landscape presents a fundamental shift as regulatory frameworks evolve beyond traditional efficacy-first approaches. The most significant patient impact now comes from innovations that enhance safety profiles of existing therapeutic…

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TuesdayAug 19, 2025 9:45 am

Lantern Pharma Inc. (NASDAQ: LTRN) Releases Latest AI Breakthrough for Central Nervous System (‘CNS’) Drug Development with predictBBB.ai (TM): A High-Accuracy Open-Access AI Drug Development Tool

Lantern Pharma has publicly launched predictBBB.ai (TM), its AI-driven module for predicting small-molecule blood-brain barrier permeability. The tool achieves 94% prediction accuracy, with 95% sensitivity and 89% specificity, based on real-time ensemble machine learning. Powered by Lantern’s vast molecular features data lake and ensemble algorithms, the platform sets a new computational benchmark for CNS drug discovery. Lantern hosts additional predictive and analytical modules in development, leveraging its large-scale data infrastructure and algorithmic approach. The tool is publicly accessible through a freemium model, aiming to drive adoption, strategic partnerships, and accelerate CNS therapeutic development. Lantern Pharma subsidiary Starlight Therapeutics secures FDA IND clearance…

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TuesdayAug 19, 2025 9:45 am

Izotropic Corporation (CSE: IZO) (OTCQB: IZOZF): How a $500K Device Could Reshape the $8.7 Billion Breast Imaging Market

IzoView Breast CT targets aggressive market displacement with up to 67% lower pricing than competing breast CT systems, positioning at $500K versus competitors priced up to $1.5 million True 360-degree 3D imaging without compression positioned to bridge the clinical gap between standard screening and MRI, offering 100x greater spatial resolution than MRI at significantly lower cost Platform approach enables 14 potential future indications across screening, diagnosis, monitoring, and treatment planning through software upgrades, creating scalable revenue expansion without hardware replacement Every year, outdated imaging technologies underperform for the roughly half of women undergoing breast cancer screening who have dense breast…

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FridayAug 15, 2025 12:45 pm

Soligenix Inc. (NASDAQ: SNGX) Working to Advance Heat-Stable Ricin Vaccine with Promising Efficacy

Ricin toxin is a potent biothreat, so lethal that even a dose the size of a grain of salt can be fatal within 48 to 72 hours. RiVax(R) is a subunit protein vaccine that incorporates Soligenix’s ThermoVax(R) technology, which eliminates the need for cold-chain storage.  Soligenix reports that the RiVax antigen has been shown to be safe in phase 1 studies in humans, with future steps including pivotal animal efficacy studies. With global security threats driving demand for advanced biodefense solutions, Soligenix (NASDAQ: SNGX) is advancing RiVax(R), a heat-stable recombinant vaccine candidate aimed at protecting against deadly ricin toxin exposure.…

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FridayAug 08, 2025 9:00 am

Izotropic Corp. (CSE: IZO) (OTCQB: IZOZF): The Cancer Detection Revolution That Could Make Breast Cancer Deaths Preventable

Izotropic’s IzoView Breast CT Imaging System represents a breakthrough in dedicated breast imaging technology, addressing persistent limitations in conventional screening methods through proprietary hardware and software FDA regulatory pathway alignment clears the path for a pivotal U.S. clinical study, with the company completing a comprehensive 150-page strategic business plan and advanced financial modeling for commercialization Strategic awareness initiatives including dedicated breastct.com platform and podcast series position the company for market education as breast CT technology emerges as the next generation of cancer detection The medical community stands at the threshold of what could become the most significant advancement in cancer…

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ThursdayAug 07, 2025 10:30 am

Izotropic Corp. (CSE: IZO) (OTCQB: IZOZF) Advancing Next-Gen Breast Cancer Imaging

Breast cancer continues to be the most commonly diagnosed cancer among U.S. women, excluding nonmelanoma skin cancer Izotropic is preparing to revolutionize breast cancer imaging with its flagship IzoView Breast CT Imaging System In anticipation of future commercialization, Izotropic is initiating a strategic awareness and engagement campaign Accurate detection and diagnosis remain critical challenges in the fight against breast cancer, especially for women with dense breast tissue where mammography falls short. Izotropic (CSE: IZO) (OTCQB: IZOZF) is at the forefront of addressing these gaps through its IzoView Breast CT Imaging System, a contrast-enhanced CT platform designed for enhanced screening precision. The company…

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ThursdayAug 07, 2025 9:00 am

Lantern Pharma Inc. (NASDAQ: LTRN) Completes Japanese Enrollment for LP-300 Phase 2 HARMONIC(TM) Trial Ahead of Schedule

The trial targets never-smoker non-small cell lung cancer (“NSCLC”) patients, a group with limited treatment options. Japan’s high incidence of never-smoker NSCLC makes it a strategic region for the trial. LP-300 is being tested alongside standard chemotherapy agents in patients who have relapsed after tyrosine kinase inhibitor therapy. Lantern's AI-driven approach may help identify and accelerate development of therapies in underserved cancer markets. Additional trial data from Taiwan and the U.S. is expected later in Q3 2025. Lantern Pharma (NASDAQ: LTRN), a clinical-stage biotechnology company leveraging artificial intelligence and machine learning to redefine oncology drug development, has completed targeted patient…

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WednesdayAug 06, 2025 12:10 pm

Lantern Pharma Inc. (NASDAQ: LTRN) Launches AI Tool to Predict Efficacy of Cancer Drug Combinations

Lantern Pharma has introduced an AI-powered module within its RADR(R) platform to assess DDA-DDRi combination therapies. The module uses genomic, transcriptomic, and clinical data, to predict treatment synergy and patient response, and supported the design of Lantern’s FDA-cleared Phase 1B/2 trial in triple-negative breast cancer. A review of 221 clinical trials informed the development of the predictive algorithm. Non-PARP DDRi combinations with DNA-damaging agents showed strong outcomes in specific cancer subtypes. Lantern is evaluating licensing opportunities to commercialize the module for broader oncology use. Lantern Pharma (NASDAQ: LTRN), a clinical-stage biotechnology company leveraging artificial intelligence and machine learning to redefine…

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