FDA filing Archives - Top News Guide

22nd Century Group (OTC: XXII) Files FDA Renewal for VLN® MRTP Status

May 12, 2026

Market Overview 22nd Century Group, Inc. (OTC: XXII) continues to navigate the complex regulatory environment surrounding tobacco products as it works to maintain its position in the market. The company’s stock has drawn attention from investors interested in tobacco alternatives and regulatory developments impacting the industry. Market sentiment reflects cautious optimism as 22nd Century Group pushes forward in its quest for longer-term modified risk marketing authorization. In recent months, 22nd…

Arht Media Inc. (OTC:ARHTF) Stock In Focus After Latest News

If you are currently on the lookout for new-age innovative companies, then it could be a good move to get a better idea about Arht Media Inc. (OTC:ARHTF). The company is a worldwide leader in developing low-latency, high-quality holograms and digital content. Yesterday, the company was in the news cycle after it announced that it had gone into collaboration with Provision Events pertaining to an innovative project with Hoag, the Orange County, United States-based non-profit organization. The company noted that the collaboration had been created with the aim of bringing about a path-breaking fan experience at the PGA Tour Champions Event, the Hoag Classic 2024. The event had been scheduled to take place from March 22 to March 24 at the Newport County Beach Club. Those in attendance at the event had the opportunity to get a firsthand experience of the inventiveness of hologram displays. It was also noted that the visitors at the Hoag Experience Lounge had engaged with the holographic representations of executives, doctors, and nurses associated with Hoag, who had been responsible for providing healthcare information with regards to the Hoag Compass healthcare services. The Chief Marketing Officer of Hoag Cara Uisprapassorn spoke about the latest developments yesterday. She noted that due to the forward-thinking ways it operated at an organization, it allowed Hoag to engage with the public in innovative ways. She went on to state that at the 2024 Hoad Classic, the hologram provided a novel way for more than 71,000 fans to connect with the Hoag brand and set a new benchmark for community engagement practices. The Chief Executive Officer of Arht Media, Larry O’Neill, stated that everyone at the company was thrilled at the collaboration that created a unique and immersive experience for the fans. It remains to be seen if the stock gets any action in the coming days.
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BlockQuarry Corp (OTC:BLQC) and Pantheon Resources Embrace Leadership Transition, Introduce Interim CEO and CFO, Stephen Stenberg

There were a number of companies that came into the news cycle yesterday, and one of those was BlockQuarry Corp. (OTC:BLQC), an energy and infrastructure company based out of Texas. On December 18, the company announced that its corporate leadership had entered a transformative phase. It was revealed that BlockQuarry had agreed on the terms with regards to a change of control that would effectively allow for voting control across its executive team. Additionally, the company also announced it had appointed a new Chief Executive Officer/Chief Financial Officer in the form of Stephen Stenberg, who would be a highly important member of the executive leadership team at BlockQuarry Corp. Davis expressed confidence in Stenberg’s leadership, stating: “Stephen’s expertise will usher in a transformative phase for BlockQuarry, promising tremendous value, strategic growth and unparalleled innovation.” It could be a good move on the part of market watchers to take a look at the new terms. As per those terms, Alonzo Pierce, the former president and chairman, formally gave up his president title. Instead, he extended that title to Lawrence Davis, the current Chief Operating Officer of BlockQuarry Corp. In the news release, it was noted that the move would help the company get to the next stage of its growth, both at financial and operational levels. Pierce would continue to be the chairman and senior advisor at the company. Additionally, Pierce also shared the vision of the integration and noted that the changes were important for the company as it looked to scale higher heights in the energy, bitcoin mining, and infrastructure industries. The company announced that the new interim CEO/CFO of the company, Stenberg, had had a fruitful career in the equity markets. During his career, he has shown the ability to restructure financial frameworks and deploy highly advanced data science solutions. He had shown his mettle at Pantheon Financial Partners most recently and further demonstrated his ability to strengthen the financial health of an organization.
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Ensurge Micropower (OTCMKTS:ENMPY) Stock Gains Momentum: What’s The Buzz?

Ensurge Micropower (OTCMKTS:ENMPY) is involved in providing solid-state lithium microbatteries for the latest generation of hearables, wearables and IoT (Internet of Things) devices. The company was in focus on Monday after it announced that it had been producing packaged lithium solid-state batteries reliably and the manufacturing flow had also improved. The micro batteries in question are of the high-performance variant. While it cannot be denied that the announcement indicated considerable progress on the manufacturing front, Ensurge Micropower made another key announcement as well. The company announced yesterday that it had started producing high-capacity multi-layer solid-state lithium microbatteries in sample volumes. These batteries are being manufactured by the company through deployment of its unique and innovative architecture, which is based on a 10-micron stainless steel substrate. The company’s Chief Executive Officer Mark Newman spoke about the development as well. He noted that both the milestone were highly significant for Ensurge Micropower since the company was working on scaling up its production capabilities for specific markets. He went on to assert that he believed that the batteries manufactured by the company were going to bring about a revolution in the way next-generation products were going to be designed.
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Herborium Group (OTCMKTS: HBRM) Financials Trend Up Signaling Major Catalysts

Herborium Group, Inc. (OTCMKTS: HBRM) is uniquely positioned at the nexus of two rapidly growing multi-billion dollar markets (1. Natural Skin Care, 2. Acne Treatment and other skin health concerns)HBRM’s Revenue and Earnings continue to trend up HBRM’s cash flow is higher than ever, positioning the company for significant growth in 2022. Herborium Group is a Natural Botanical Therapeutics® Company Maintaining Pharmaceutical Standards and Efficacy HBRM offers a unique combination of products and content in the natural skincare sector. Presently focused on acne treatment and prevention the company tests its natural formulations with the same standards found in the pharmaceutical industry creating higher efficacy, proven safety, and consumer satisfaction. The company is now set to roll out an AI technology platform that will allow its consumers to diagnose the products they need utilizing the company’s proprietary skin diagnostic software. HBRM’s SKIN-NATURA is a curated platform providing integrated, natural, safe, and efficacious products and treatment regimens. This is complemented by support content and personalized know-how focused on skin health and beauty (in the field of dermatology, nutrition, and cosmetology). The platform is driven by AI-based technology to streamline both the diagnostic and deliverables. This allows for seamless integration of the most desirable products and content provided by the company and the NATURA Consortium. Consumers benefit from a comprehensive solution to their needs, delivered in an expedient and user-friendly manner, and at the optimal price point. Herborium will realize multiple revenue streams and brand-building benefits from this program. Consortium partners benefit from cooperative marketing power, innovative technology to interact with consumers, and the Skin Natura brand and expertise. Many companies claim they have natural products for skin problems. The issue is the ‘natural’ buzzword is being used without accountability for efficacy or quality. This is where HBRM shines, the company is a legacy ‘natural’ care company with high-quality efficacy and safety standards, for its own Botanical Therapeutics the Company uses clinical validation and a proactive regulatory strategy based on the FDA’s Botanical Drug Development Guidance for Industry, 2016 to establish and maintain a differential market advantage. Herborium harvests its proprietary therapeutic candidates from Traditional Chinese Medicine with initial confirmatory data and utilizes Western regulatory, clinical, and marketing strategies to successfully introduce the products to the Western markets. This strategy serves to mitigate risk in product development and fortifies marketing strategies. Herborium’s AcnEase product comes with a number of benefits for acne users including: Affordable, effective treatment for acute and chronic acne.Treatment that is safe, all-natural (botanical), and can be used on a longer-term basis.Suitable for females and males; contains no phytoestrogens or other hormone-altering ingredients.Prevents acne scar formation.Provides pain relief for cystic acne and eliminates the need for surgery or steroid injections.Convenient vitamin-like small tablets suitable for all ages, skin tones, and severity of acne.Relief for rosacea-related facial flushing due to dilated blood vessels.Eliminates skin sensitivity and outbreaks due to rosacea Alleviates eye irritation and gastric reflux symptoms secondary to rosacea. HBRM’s Market Opportunity 75% of all people will develop acne, and about 90% of people have some form of skincare concerns, Herborium Group, Inc. (OTCMKTS: HBRM) is uniquely positioned at the nexus of two rapidly growing multi-billion dollar markets 1. Natural Skin Care – The global natural skin care products market size was valued at USD 6.7 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 6.6% from 2022 to 2030. (Grand View Research) 2. Acne Treatment – The global acne treatment market is projected to grow from $9.36 billion in 2022 to $12.97 billion by 2029, exhibiting a CAGR of 4.8% during the forecast period. (Fortune Business Insights) Over 60 million people in the U.S. have acne, and contrary to popular belief, it’s not a condition that only affects teenagers. In fact, the average age of people suffering from acne is 26.5, which is five years older than the average age was just a decade ago. The European acne market is estimated to represent over 120 million individuals, and the Asian and Latin American markets are estimated to be 5 to 7 times larger. In addition, due to a number of factors such as pollution, diet, lifestyle and even genetics, acne is often a chronic disease. The company has gained market share steadily over the past 4 years, and with the launch of its new AI technology could see accelerated growth in 2022. Potential Catalysts for HBRM HBRM announced its highest positive cash flow number ever at the end of fiscal 2021 ($110k). It has used this cash flow to accelerate development and it appears to be paying off.Catalyst #1: Launch of AI TechnologyHBRM’s AI-based platform for integrated product, content, and expertise in the area of skincare SKIN-NATURA® is expected in the 4th Quarter of 2022. Catalyst #2: Q3 FinancialsHBRM’s financial results have been trending up for years. With Q3 closing at the end of August, any guidance on these numbers could send the stock upward.There are several other potential catalysts that we may not be aware of, but the above two are near certainties that would have a positive effect on the stock. Make sure to start your research on HBRM today! This article is part of a sponsored investor education program
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WHSI Positioned to Earn Market Share in Telehealth as TDOC Tumbles

WHSI’s new 4G device is anticipated to launch in late-AugustWHSI has announced its device will serve the virtual care/ telehealth marketTelehealth is seen growing by 32.1% annually over the next 6 years According to Fortune Business Insights, the global telehealth market size is anticipated to reach $636.38 billion by 2028 and exhibit a CAGR of 32.1% during the forecast period. The ubiquity of smartphones and the paradigm-changing pandemic have made telehealth and virtual care the ‘new normal.’ Recognizing this, Wearable Health Solutions, Inc. (OTCMKTS: WHSI) has announced with its 4G release in late August, the company expects to launch an entire expanded ecosystem of products to its dealer and vendor networks with a Remote Patient Monitoring (RPM) vertical initiative that will integrate existing monitoring hardware and software solutions into a complete ecosystem to streamline and simplify care of chronically ill patients. Investors have done well in the telehealth market recently. Teladoc Health (NYSE: TDOC) is up 25% in the last 30 days, DexCom, Inc. (Nasdaq: DXCM) is up 14% over the same period. Many of the other leaders in the space are private but have seen venture capital come in bunches. WHSI will now attract investors in the space with a taste for speculation. The company is set to launch a brand new device that could dramatically expand its already healthy customer base of 8,000 end users plus an order book of about 2,000+ potential activations. “We have engaged industry marketing experts and working with advisors specifically to help deploy the RPM and Chronic Care Management solutions to be implemented by physicians groups, healthcare systems, HMOs, Pharmaceutical companies, and to be user-friendly for patients on a daily basis, stated Peter Pizzino President, “the company expects to increase its revenues and profitability as a result of the RPM product offering”. Teladoc investors may be in profit-taking mode after yesterday’s disappointing Q2 numbers and FY guidance. The company lost $3 billion and cited concerns that smaller competitors are taking market share from its “Better Health” product. WHSI will be one of those competitors with its 4G iHelp Max. The telehealth market is expanding rapidly, however, with any fast-growing new market it is still shaking out. First movers like Teladoc and DexCom were able to secure a large share of public investment, but as reflected in TDOC’s latest financials it is struggling to translate that capital into market share. WHSI, is an earlier stage and gives investors more near-term upside from its current share price. Telehealth investors should start their research on WHSI today: https://topnewsguide.com/wearable-health-solutions-inc-whsi-profile/ This article is part of a sponsored investor education program.
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Wearable Health Solutions, Inc. (OTCMKTS: WHSI) Readies Launch of 4G Product ‘Ecosystem’

Wearable Health Solutions, Inc. (OTCMKTS: WHSI) will launch an ‘ecosystem’ of new products and services to its dealer networks in August. Included are WHSI’s 4G device, docking station and wrist bands, according to Peter Pizzino, president of WHSI, who also noted a “variety of bundled features of the new 4G mobile medical alarm” will be available as well. This is WHSI’s latest innovation in the $30+ billion market of remote Virtual Care and patient monitoring solutions. WHSI’s Catalyst is the 4G iHelp Max Device Key to WHSI’s plans is its debut of the 4G iHelp Max personal care device. WHSI is positioning itself for a leadership position in the new 4G technology in the growing home security and home healthcare markets. Research firm MarketsAndMarkets projects this market will grow at a CAGR of 38.2% to reach $117 billion by 2025. As 3G devices are phased out, WHSI’s new 4G devices offer dealers and vendors next generation iHelp MAX™ 4G features. These include Wi-Fi, NFC (wireless data transfer) technology and Bluetooth 4.0 Low Energy. WHSI Files For Up List, Seeks $5 Million From Capital Markets WHSI is offering investors additional compelling reasons to add the company stock to Watch Lists. WHSI has filed its Form 10 with the SEC for an up list to the OTC: QB market. WHSI’s strategy to become a fully reporting company to the SEC and up list to another trading exchange. The goal: increased visibility to the financial investment community. That also means increased access to the capital markets. WHSI says it plans to raise $5 million in financing in various forms. The funds would be used to expedite the launch of its next generation mobile medical device. This would include its Lone Worker Program initiative. WHSI Retains International Monetary (IM) WHSI has also retained International Monetary (IM), a full service merchant banking and strategic advisory firm. M. B. (Blaine) Riley, III, managing director and president of IM, says, “We will introduce the company to our nationwide brokerage network comprised of broker-dealers and investment banks focused on the micro-cap and small-cap sectors,” he said. “While on the investor relations side, we will direct a series of initiatives to the investment community for enhancing shareholder value and market awareness.” Why It Matters WHSI is investing in R&D, exclusive and proprietary software and a new cloud-based portal for its 4G remote monitoring device.WHSI is offering the robust growth PERS market and its dealer innovation in 4G technology. WHSI is integrating the newest technology, such as voice artificial intelligence (AI), into its existing Smart products. They offer call integration with Alexis and Google, telehealth-ready monitoring wearables plus AI, BlueTooth, IoT, Central Cloud Management, Backend As A Service (Baas) and more. Telehealth Vitals Will Offer Indicators To Medical Professionals WHSI plans to deliver more telehealth features in the future through peripherals such as The iHelp Next Generation Platform (NGP). A biosensor being developed now will feed telehealth vitals into a portal. It will enable medical professionals to see indicators such as temperature, heart rate, pulse, blood pressure (cuffs), glucose monitoring and more. WHSI A Multi-Stream, High Technology Revenue Company WHSI is a multiple revenue stream company. It sells high-technology wearable devices and body mounted sensors internationally. It also operates a subsidiary, Medical Alarm Concepts LLC (MAC), which works with numerous monitoring stations. Keep WHSI stock on your watch list as it integrates technology into its increasingly sophisticated monitoring products. It competes in several dynamic remote monitoring growth markets. For more information, go to wearablehealthsolutions.com This sponsored article is part of an investor education program.
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How ESG Reporting Can Help All Public Companies Improve Investment In Flow

ESG or Environmental, Social and Governance have become increasingly important to investors during the decision-making process. As investor interest has grown in ESG, products and services marketed as such have proliferated, according to Bloomberg Intelligence ESG assets are set to balloon to $50 trillion by 2025 from about $35 trillion.
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How Distribution Could Effect SHNJF Stock

According to Research and Markets, the North American spirits market is expected to reach USD 278.5 billion by 2028, registering a CAGR of 7.7% over the forecast period. Rogue Baron PLC. (OTCMKTS: SHNJF) is one company we’ve been eyeing that has a major opportunity to grab a slice of this rapidly growing market. How SHNJF is Positioned to Accelerate its Revenue Growth Rogue Baron (OTCMKTS: SHNJF) believes if it can reach 10,000 cases sold annually, Shinju will be worth $50 million.SHNJF currently sells 3,000 cases of Shinju Japanese Whiskey annually.7,000 more cases annually would only represent 0.1% of the average annual liquor market growth in the US alone. SHNJF’s Shinju is a high-end liquor with a reasonable price in a fast-growing market, so these projections could be considered conservative.Shinju’s trophy case is impressive: Sante Spirits 2021 Best in Class Sante Spirits 2021 Best WhiskeySante Spirits 2021 Double GoldFifty Best World Whiskey 2021 Silver MedalJohn Barleycorn 2021 Taste Competition Gold Medal WinnerJapanese Whiskey Market Growth in the US is Accelerating:2010 US imports of Japanese whiskey were $1 million 2019 US imports of Japanese whiskey were $50 million Distribution is the Key to SHNJF’s Growth Potential When building a successful liquor brand the key to success is distribution. Distributors help market brands through their network, and if a company is marketing itself, it needs to be sure that retailers carry their product otherwise they lose potential sales. SHNJF has secured European distribution, it delivered its first shipment to the UK market recently. A large catalyst for the stock, however, will be if the stock can complete a deal or two with US/ North American distributors. A few distributors to keep an eye on include: Southern Glazer’s Wine & Spirits- With over 22,500 employees and $21 Billion in annual sales, Southern Glazer is the nation’s largest wine and spirits distributor. The company began in Florida in 1968 and grew quickly through a strategy of acquiring other established distributors. Today Southern operates in 44 states and distributes over 7,000 brands.Breakthru Beverage Corp.- operates in 13 states and the District of Columbia, with sales over $5.6 Billion.Republic National Distributing Company (RNDC)- second largest beverage alcohol distributor of premium wine and spirits in the U.S. with wholly owned operations in Alabama, Colorado, District of Columbia, Florida, Louisiana, Maryland, Mississippi, Nebraska, North Carolina, North Dakota, South Dakota, Texas, Virginia, and West Virginia. RNDC also operates in Arizona, Indiana, Kentucky, Ohio, Oklahoma, and South Carolina through venture partnerships. In total, RNDC employs more than 7,000 hard working individuals nationwide.Empire Merchants North LLC- employs 623 associates and distributes approximately five million cases per year. EMN is the only major locally owned distributorship in upstate New York.Fedway Associates, Inc.- one of the leading distributors in the state of New Jersey. Any deals with one or several of these distributors could catapult SHNJF to a new level. Early investors will benefit. Start your research here: https://topnewsguide.com/japanese-whiskey-offers-early-investors-big-profit-potential/ This article is part of a sponsored investor education program.
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