Breaks Categories: News

TuesdayDec 02, 2025 9:20 am

BioMedNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Announces FDA Receipt of ANDA for KETAFREE With July 2026 Review Goal Date

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, said the FDA has received its Abbreviated New Drug Application for KETAFREE(TM), a preservative-free intravenous ketamine formulation, deeming the submission “substantially complete” and assigning a July 29, 2026 review goal date. CEO Jonathan Javitt said KETAFREE is designed to provide a single-patient, preservative-free alternative to current multidose ketamine vials that contain Benzethonium Chloride, a compound no longer recognized as safe by the FDA. The Company said KETAFREE aligns with MAHA initiatives to remove toxic substances from medicines and supports domestic supply-chain priorities, with potential 2026 approved drug sales if approved on schedule.…

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TuesdayDec 02, 2025 9:10 am

BioMedNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) Schedules Corporate Update Call for Dec. 2

NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, said it will host a corporate update conference call on Dec. 2, 2025, at 9 a.m. Eastern to review recent clinical, regulatory and operational developments. To view the full press release, visit https://ibn.fm/ZSIqm About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal…

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MondayDec 01, 2025 9:50 am

BioMedNewsBreaks – NRx Pharmaceuticals, Inc. (NASDAQ: NRXP) to Present at NobleCon21

NRx Pharmaceuticals (NASDAQ: NRXP) said Founder, Chairman and CEO Jonathan Javitt, M.D., M.P.H., will present at NobleCon21 on Dec. 3 at 4:30 p.m. EST, offering an update on the company’s expanded focus in investigational drugs, medical devices, and interventional psychiatric therapies for suicidal depression, PTSD, and related conditions, as well as progress in generating clinical revenue since NobleCon 2024. To view the full press release, visit https://ibn.fm/4Gi6M About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain,…

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MondayDec 01, 2025 9:15 am

BioMedNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Outlines Regulatory Strategy After NSE Decision on ECG Synthesis Software

HeartBeam (NASDAQ: BEAT), a medical technology company developing personalized cardiac-care insights, detailed its strategy following receipt of a Not Substantially Equivalent decision for its 510(k) submission covering its 12-lead ECG Synthesis Software. The Company has been in active discussions with FDA review staff, which have signaled willingness to work toward a constructive resolution. HeartBeam said its VALID-ECG clinical study met endpoints and that remaining FDA concerns may be resolved through revised labeling. To advance the process, the Company plans to pursue multiple parallel paths—including a formal appeal or a 510(k) resubmission—and believes recent interactions indicate a viable path forward under…

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WednesdayNov 26, 2025 3:52 pm

BioMedNewsBreaks — Nano-X Imaging Ltd. (NASDAQ: NNOX) Announces $15 Million Registered Direct Offering 

Nano-X Imaging (NASDAQ: NNOX) entered a securities purchase agreement with a single institutional investor to sell 3,826,530 ordinary shares in a registered direct offering expected to generate approximately $15 million in gross proceeds, with Titan Partners Group, a division of American Capital Partners, serving as sole placement agent. Closing is expected on or about Nov. 25, 2025, and the company plans to use the net proceeds for working capital and general corporate purposes. To view the full press release, visit https://ibn.fm/T8nKT About Nano-X Imaging Ltd. Nanox (NASDAQ: NNOX) is focused on driving the world’s transition to preventive health care by…

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TuesdayNov 25, 2025 1:27 pm

BioMedNewsBreaks — Branded Legacy, Inc. (OTC: BLEG) Reports $125,000 Q3 Revenue from Pau Hana as Company Expands Kava Bar Growth Strategy 

Branded Legacy (OTC: BLEG), a provider of addiction treatment and harm-reduction solutions, reported third quarter revenue of just over $125,000 from its newly acquired Pau Hana subsidiary, a cash-flow-positive kava bar in West Melbourne, Florida. The company said Pau Hana’s strong daily retail performance provides a stable new revenue pillar and will serve as the blueprint for an aggressive 2026 expansion, including plans to open three to five new Florida locations and pursue additional acquisitions of profitable kava bars. Branded Legacy aims to build a scalable roll-up platform that layers centralized sourcing, branding and operational efficiencies across acquired venues, positioning the…

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TuesdayNov 25, 2025 9:00 am

BioMedNewsBreaks – Oncotelic Therapeutics, Inc. (OTCQB: OTLC) Featured in BioMedWire Editorial on Rising Biotech Valuations

Oncotelic Therapeutics (OTCQB: OTLC) announced its inclusion in a BioMedWire editorial highlighting how fair-value adjustments under U.S. GAAP are emerging as key indicators of scientific and commercial progress across the biotech sector. The article spotlights Oncotelic’s upcoming fair-value update on its 45% ownership in JV partner GMP Bio, following an independent assessment showing a significant increase in asset value, reinforcing the company’s position among leaders advancing oncology treatments. To view the full press release, visit https://ibn.fm/aAZ0k About Oncotelic Therapeutics Inc. Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on the development of oncology and immunotherapy products. The company’s mission is…

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MondayNov 24, 2025 9:40 am

BioMedNewsBreaks – Nutriband Inc. (NASDAQ: NTRB) Announces Chairman Presentation at NobleCon21

Nutriband (NASDAQ: NTRB) announced that Chairman and Co-Founder Serguei Melnik will present at NobleCon21, Noble Capital Markets’ annual emerging growth equity conference, on Dec. 3 at 9:30 a.m. Eastern at Florida Atlantic University’s Executive Education Complex in Boca Raton, Florida. Investors and guests may attend at a discounted rate using code NTRBNOBLECON, and a high-definition webcast will be available the following day at nobleconference.com and Channelchek.com, where it will remain archived for 90 days. To view the full press release, visit https://ibn.fm/CqOt4 About Nutriband Inc. We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our…

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MondayNov 24, 2025 9:00 am

BioMedNewsBreaks – HealthLynked Corp. (OTCQB: HLYK) Engages NE Holdings to Guide Nasdaq Listing Strategy

HealthLynked (OTCQB: HLYK) said it has entered a Capital Market Advisory Agreement with “NE Holdings LLC,” a Florida-based consulting firm focused on senior exchange readiness and capital markets strategy, to support the Company plan to uplist to Nasdaq in the first half of 2026. NE Holdings will lead corporate and financial readiness efforts, oversee audit and compliance planning, assist with capital structure optimization, coordinate introductions to investment banks and key market participants, and advise on governance as HealthLynked advances its Nasdaq listing roadmap and broader public-market expansion strategy. To view the full press release, visit https://ibn.fm/ZxSyM About HealthLynked Corp. HealthLynked…

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FridayNov 21, 2025 9:20 am

BioMedNewsBreaks – Oncotelic Therapeutics, Inc. (OTCQB: OTLC) Featured in BioMedWire Editorial on Biotech Valuation Trends

Oncotelic Therapeutics (OTCQB: OTLC) was highlighted in a BioMedWire editorial examining how fair-value remeasurements under GAAP are becoming key indicators of real scientific and commercial progress in late-stage biotech pipelines. The piece notes that Oncotelic is preparing for a significant fair-value remeasurement of its 45% stake in JV entity GMP Bio following a new independent valuation suggesting a potential step-up in asset value, reinforcing the company’s position as it advances its oncology efforts. To view the full press release, visit https://ibn.fm/YS5OI About Oncotelic Therapeutics Inc. Oncotelic Therapeutics is a clinical-stage biopharmaceutical company focused on the development of oncology and immunotherapy…

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