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2,646 stories matching this filter · ← front page

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  • Woman travels to Albania for experimental mitochondrial replacement therapy amid global fertility industry concerns
    A STAT reporter detailed a case of a woman named Heidy Willis who, after multiple failed IVF cycles, sought an experimental fertility option abroad. Willis traveled to Albania to undergo mitochond…
    STAT · 8d agoNegative↗ source
  • Pharma leaders turn to integrated scenario modeling as US MFN pricing reshapes global launch strategies
    The article explains that integrated scenario modeling is becoming a key tool for pharmaceutical executives facing pricing uncertainty and the complexities of worldwide product launches. It refere…
    BioPharma Dive · 8d agoNeutral↗ source
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Women travel abroad for unproven three-parent IVF marketed to older patients
STAT investigators found that women are journeying thousands of miles to undergo a mitochondrial‑replacement IVF procedure that is promoted as a fertility option for older patients, even though the…
STAT · 8d agoNegative↗ source
  • FDA approves generic lenacapavir for low-income markets; EMA to review Lundbeck's Deanxit over safety concerns
    The U.S. Food and Drug Administration has granted approval for a generic version of lenacapavir, a drug aimed at treating HIV, with the intention of making it available to lower-income countries.…
    raps · 8d agoApprovalNeutral↗ source
  • Midterm voters weigh health-care costs as urgent-care visits billed like ERs
    The upcoming midterm elections will see tens of millions of voters consider health‑care affordability, especially those whose coverage comes through their employers. The article points out that ri…
    STAT · 8d agoNegative↗ source
  • Study finds patient agreement forms match knowledge surveys, urging greater transparency in FDA’s mifepristone REMS
    A randomized controlled trial published in JAMA Internal Medicine examined how well patients understood medication abortion when they signed the FDA’s risk evaluation and mitigation strategy (REMS)…
    raps · 8d agoRegulatoryNeutral↗ source
  • Study finds psilocybin does not produce lasting anxiety or depression relief in mice
    Five Bay Area laboratories joined forces to examine whether a single dose of psilocybin could produce lasting reductions in anxiety and depression-like behavior in mice. The study measured behavior…
    STAT · 8d agoNegative readoutNegative↗ source
  • Cancer can be treated safely during pregnancy, says maternal-fetal specialist
    Elyce Cardonick, a maternal-fetal medicine physician and founder of the Cancer and Pregnancy Registry, argues that pregnant cancer patients are often urged to terminate their pregnancies even thoug…
    STAT · 8d agoPositive↗ source
  • Australian regulator opens consultation on clinical trial data sharing and ICH GCP guidance
    The Therapeutic Goods Administration (TGA) in Australia has launched a public consultation seeking input on how clinical trial information should be shared under existing schemes. The consultation…
    raps · 8d agoRegulatoryNeutral↗ source
  • STAT calls for input on mitochondrial replacement therapy used in fertility tourism
    STAT is asking patients and clinicians to share their experiences with mitochondrial replacement techniques (MRT), sometimes called three-parent IVF, which are being marketed as a fertility option…
    STAT · 8d agoNeutral↗ source
  • Brad's Raw Chips recalls kale chips over potential thallium contamination
    Snack Right Super Foods, doing business as Brad's Raw Chips, announced a recall of certain Brad's Plant Based Crunchy Kale (2 oz) and Brad's Veggie Chips Kale (3 oz) products because they may conta…
    fda recalls · 8d agoCRLNegative↗ source
  • Midterm election outcomes could reshape U.S. health policy, experts say
    The article notes that regardless of the results, the upcoming midterm elections will have broad effects on the U.S. health system, according to more than two dozen policymakers, lobbyists and expe…
    STAT · 10d agoRegulatoryNeutral↗ source
  • Moderna and Merck’s individualized cancer vaccine shows promising melanoma results but shares tumble after ESMO presentation
    Investors closely watched the European Society for Medical Oncology (ESMO) meeting for updates on an individualized neoantigen cancer vaccine being co‑developed by Moderna and Merck. The therapy, c…
    BioPharma Dive · 11d agoPositive readoutNeutral↗ source
  • Lilly beats forecasts and raises outlook as Novartis steadies and GSK faces investor pressure
    Lilly reported third‑quarter revenue that exceeded analysts' expectations by about 8%, driven by strong demand for its diabetes and obesity treatments Mounjaro and Zepbound. The company also lifted…
    BioPharma Dive · 11d agoEarningsPositive↗ source
  • Setara Biosciences launches with $90 million to pursue Charcot-Marie-Tooth and other rare-disease therapies
    Setara Biosciences announced its formation on Friday, backed by $90 million of financing to advance a pipeline of experimental medicines. The company’s first candidate targets the genetic disorder…
    BioPharma Dive · 11d agoDealPositive↗ source
  • Aspen Neuroscience raises $140M IPO to advance Parkinson’s cell therapy
    Aspen Neuroscience, a San Diego biotechnology company, completed an initial public offering, selling roughly 9.4 million shares at $15 each and raising about $140.6 million. The capital will be di…
    BioPharma Dive · 11d agoDealPositive↗ source
  • Podcast examines Merck and Moderna’s mRNA cancer vaccine data presented at ESMO
    The latest episode of STAT’s biotech podcast "The Readout LOUD" focused on the mRNA cancer vaccine being co‑developed by Merck and Moderna, using data shown at the European Society for Medical Onco…
    STAT · 11d agoNeutral↗ source
  • Congress must restore independence of scientific advisory panels after controversial firings
    The authors note the recent dismissal of two vice chairs of the U.S. Preventive Services Task Force by HHS Secretary Robert F. Kennedy Jr., stressing the panel’s role in reviewing evidence to guide…
    STAT · 11d agoRegulatoryNegative↗ source
  • STAT reporters outline how upcoming midterms could reshape US vaccine, drug policy and the MAHA movement
    STAT's weekly video series STATus Report aired from Boston, the historic heart of American democracy, as the nation heads toward the midterm elections. The episode features reporters from the D.C.…
    STAT · 11d agoNeutral↗ source
  • FDA and CMS work to prevent regulatory clash as states move to test clinical AI
    Officials at the FDA and CMS are working behind the scenes to avoid a regulatory clash as more states plan to test artificial intelligence tools that perform clinical tasks. The tension arises fro…
    STAT · 11d agoRegulatoryNeutral↗ source
  • FDA rolls out new inspection coordination plan, lifts estradiol patch warning and HHS permits compounding of six peptides
    FDA's drug center and inspections office have agreed on a new concept of operations (ConOps) to better coordinate inspections and compliance activities. A U.S. senator introduced draft legislation…
    raps · 11d agoRegulatoryNeutral↗ source
  • STAT+: Pharmalittle: We’re reading about AstraZeneca cost-cutting, Sun Pharma facility problems, and more
    AstraZeneca has launched a three-year cost-cutting program that aims to slice off $1.5 billion a year, with the savings reinvested in R&D.
    STAT · 11d agoRegulatoryNeutral↗ source
  • Patient billed $1,756 after routine urgent-care visit for UTI at Texas clinic
    A woman in Allen, Texas thought she was getting a standard urgent‑care treatment for a urinary tract infection. She provided a urine sample, received a diagnosis and a prescription, and paid a mode…
    STAT · 11d agoNegative↗ source
  • Election stress linked to higher risk of arrhythmias and heart attacks, study finds
    Elections can create heightened stress that may affect cardiovascular health, according to recent research. The study highlights a link between the emotional strain of voting periods and increased…
    STAT · 11d agoNegative↗ source
  • Lancet series highlights men’s health paradox and rising urgent-care costs
    The Lancet has launched a new series examining why men consistently experience poorer health outcomes than women despite advantages in certain areas. The series points to gaps in research, screeni…
    STAT · 11d agoNegative↗ source