FDA Is Looking for Expanded Power to Crack Down on Illegal Vapes
In an interview, FDA Commissioner Marty Makary said that the US is essentially wide open to shipments of dangerous products including unauthorized vapes as well as an opioid-like substance found in potent kratom extracts. Another product of concern is tianeptine, which has been dubbed 'gas station heroin' and is available at convenience stores nationwide.
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The Hidden Lung Infection Impacting Millions: World NTM Day Puts Spotlight on Awareness
With Annual NTM Case Rates Rising, Patients and Providers Are Urged to Recognize the Symptoms and Risks MIAMI, Aug. 4, 2025 /PRNewswire/ -- As the world prepares to observe World NTM Day on August 4, 2025, NTM Info & Research (NTMir) is calling on patients, physicians, caregivers, and policy leaders to shine a spotlight on nontuberculous mycobacterial (NTM) lung disease, a growing but underrecognized threat to global respiratory health. Experience the full interactive Multichannel News Release here: NTM lung disease is caused by environmental bacteria found in water and soil. While many are exposed, people with underlying lung conditions—particularly bronchiectasis—are at higher risk of infection. Alarmingly, new data show that NTM cases are rising by more than 8.2% annually, particularly among women over age 65 and individuals with chronic lung disease. The economic burden per patient can exceed $30,000 per year, underscoring the cost of delayed diagnosis and limited treatment options. "NTM lung disease is one of the most misunderstood and misdiagnosed conditions we see today," said Amy Leitman, JD, President of NTMir. "It doesn't just threaten lives—it disrupts them. But the earlier we recognize the symptoms, the better our chances of preventing severe lung damage and improving patient outcomes." Most people diagnosed with NTM also have bronchiectasis, a condition that causes permanent damage to the airways. When combined, the diseases can lead to a vicious cycle of recurring infections, declining lung function, and years of missed opportunities for proper care. "We want to empower people to listen to their lungs," said Leitman. "If someone is experiencing persistent coughing, fatigue, shortness of breath, or unexplained weight loss—don't wait. Ask your doctor if NTM could be the cause." World NTM Day: Raising Voices, Inspiring Action This year's theme, "Recognize. Respond. Rise Together," emphasizes the critical need for: Early diagnosis through improved screening protocols Patient education and community engagement Investment in research and innovation to support more effective and accessible treatments To that end, NTMir continues to lead efforts to: Deliver comprehensive educational resources on diagnosis, treatment, and ongoing clinical research Support a global network of patients and caregivers through online communities and local support groups Advocate for increased research funding and policy change to address the unmet needs of the NTM community Visit for patient stories, educational tools, clinical trial information, and ways to take action. How You Can Help: Learn the symptoms and risk factors by visiting Share social media posts, videos, and infographics using #WorldNTMDay2025 Join a support group or community event near you Encourage your healthcare providers to consider NTM in patients with unexplained respiratory symptoms Together, we can improve outcomes, expand awareness, and give a stronger voice to those living with NTM lung disease. About NTM Info & Research (NTMir):NTM Info & Research (NTMir) is a national 501(c)(3) non-profit organization formed on behalf of patients with pulmonary nontuberculous mycobacterial (NTM) disease for patient support, medical education and research. The organization serves patients, healthcare providers and researchers dealing with bronchiectasis and NTM. It advocates a broad agenda to promote early diagnosis, improved treatments, and research. The mission is to bring a voice to the concerns of all our constituents with government officials and agencies that guide, research, and regulate therapies developed to treat these diseases. NTM Info & Research recognizes the need for advancement in education and treatment of bronchiectasis. About World NTM Day 2025: World NTM Day, observed annually on August 4, is a global awareness initiative led by NTM Info & Research (NTMir) to spotlight the rising impact of nontuberculous mycobacterial (NTM) lung disease—a serious and often misunderstood condition that affects tens of thousands each year. The 2025 theme, "Recognize. Respond. Rise Together," underscores the urgent need to increase awareness, improve early detection, and empower patients and providers with knowledge. As NTM cases continue to climb and too many remain undiagnosed or misdiagnosed, World NTM Day calls on the global community to take action—by learning the signs, supporting those affected, and advancing research that brings hope for better outcomes. View original content: SOURCE NTM Info & Research (NTMir) Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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Drug Farm Announces First Patients Dosed in Phase 1b Clinical Trial Evaluating ALPK1 Inhibitor, DF-003 in ROSAH Syndrome
Trial will evaluate DF-003, a first-in-class ALPK1 inhibitor that specifically targets the genetic root cause of ROSAH syndrome ALBANY, N.Y. & SHANGHAI, August 04, 2025--(BUSINESS WIRE)--Drug Farm, a private biotechnology company utilizing genetics and artificial intelligence technologies to discover and develop innovative, immune-modulating therapies, today announced that the first human participants have been dosed in a clinical trial (NCT06395285) of DF-003 in patients with ROSAH syndrome. DF-003 is a first-in-class, immune-modulating alpha-kinase 1 (ALPK1) inhibitor that targets ALPK1 mutants causing ROSAH syndrome. The trial is evaluating the safety, pharmacokinetics and efficacy of orally administered DF-003 at sites in the USA and Australia. "We are happy to offer patients with ROSAH syndrome the opportunity to participate in a clinical trial using a new precision-targeted drug to treat the root cause of their disease," said Dr. John Grigg, Professor of Clinical and Experimental Ophthalmology, Save Sight Institute Faculty of Medicine and Health at The University of Sydney. "The initiation of this trial is a critical step forward in our goal to provide a therapeutic option in disease indications with unmet medical need that are mediated by excessive ALPK1 activation," said Henri Lichenstein, PhD, Chief Executive Officer of Drug Farm. "We are optimistic about the potential of DF-003 to make a meaningful difference in the lives of patients with ROSAH, and together with our collaborators, are committed to thoroughly investigating the safety and efficacy of DF-003 in patients with atherosclerotic cardiovascular disease as well." About DF-003 DF-003 is a proprietary, first-in-class drug developed by Drug Farm that inhibits the activity of ALPK1 and variants of ALPK1 which cause ROSAH syndrome. DF-003 has therapeutic potential for ROSAH syndrome, as well as heart and kidney diseases, as the drug has shown efficacy in preclinical models of these indications. DF-003 has completed a Phase 1 clinical trial (NCT05997641) in normal healthy volunteers and is now accruing patients with ROSAH syndrome in a Phase 1b trial (NCT06395285). About ROSAH Syndrome ROSAH (retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis and headache) syndrome is a rare, autosomal dominant autoinflammatory genetic disease named according to the characteristic symptoms exhibited by affected patients (1, 2). Disease-causing mutations in ALPK1 lead to ROSAH syndrome. The most common presenting symptom is a progressive decline in visual acuity that typically begins before 20 years of age, with ophthalmologic examination often revealing optic disc elevation, uveitis, and retinal nerve degeneration (2, 3). Most ROSAH patients also exhibit inflammatory features such as non-infectious low-grade fevers, arthralgia, headaches, and persistently elevated levels of inflammatory cytokines including tumor necrosis factor-α (TNFα), interleukin-6 (IL-6), and IL-1β (3). 1. Tantravahi SK, et al. An inherited disorder with splenomegaly, cytopenias, and vision loss. Am J Med Genet A. 2012;158(3):475-81. 2. Williams LB, et al. ALPK1 missense pathogenic variant in five families leads to ROSAH syndrome, an ocular multisystem autosomal dominant disorder. Genet Med. 2019;21(9):2103-15. 3. Kozycki CT, et al. Gain-of-function mutations in ALPK1 cause an NF-κB-mediated autoinflammatory disease: functional assessment, clinical phenotyping and disease course of patients with ROSAH syndrome. Ann Rheum Dis. 2022;81(10):1453-64. About Drug Farm Drug Farm is a private biotechnology Company developing innovative treatments targeting innate immunity for hepatitis B, heart and kidney diseases, and ROSAH (retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis and headache) syndrome. Drug Farm's unique IDInVivo platform combines breakthrough technologies in genetics and AI to discover new treatments. IDInVivo technology allows the direct assessment of gene targets in living animals with intact immune systems. Using the IDInVivo platform, Drug Farm has identified novel innate immunity pathways and targets and is now rapidly advancing multiple first-in-class drug candidates into clinical development. For more information please visit: View source version on Contacts United States:Henri Lichenstein, Executive OfficerEmail: hlichens@ China:Tony Xu, and Chief Operating OfficerEmail: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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Precision BioSciences to Report Second Quarter 2025 Results on August 7, 2025
DURHAM, N.C., August 04, 2025--(BUSINESS WIRE)--Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for diseases with high unmet need, today announced that it will publish financial results for the second quarter 2025 and provide a business update on August 7, 2025. About Precision BioSciences, Inc. Precision BioSciences, Inc. is a clinical stage gene editing company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform that differs from other technologies in the way it cuts, its smaller size, and its simpler structure. Key capabilities and differentiating characteristics may enable ARCUS nucleases to drive more intended, defined therapeutic outcomes. Using ARCUS, the Company's pipeline is comprised of in vivo gene editing candidates designed to deliver lasting cures for the broadest range of genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit The ARCUS® platform is being used to develop in vivo gene editing therapies for sophisticated gene edits, including gene insertion (inserting DNA into gene to cause expression/add function), elimination (removing a genome e.g. viral DNA such as in the HBV program), and excision (removing a large portion of a defective gene by delivering two ARCUS nucleases in a single AAV such as in the DMD program). View source version on Contacts Investor and Media Contact: Naresh TannaVice President of Investor
