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  • FDA proposal to drop adequate provision could effectively ban prescription drug ads
    FDA staff are proposing to eliminate the adequate provision requirement in direct-to-consumer prescription-drug advertisements. The adequate provision currently obliges advertisers to present a bal…
    raps · 1mo agoRegulatoryNegative↗ source
  • Pharma industry backs FDA NGS guidance but seeks clarification on off-target data and manufacturing changes
    The pharmaceutical sector has broadly endorsed the FDA's recent guidance on using next‑generation sequencing to evaluate the safety of human gene‑therapy products. Despite this support, companies…
    raps · 1mo agoRegulatoryNeutral↗ source
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  • FDA staff flag peptide conflict concerns and warn drug ad rule could curb advertising
    FDA staff have raised internal concerns about potential conflicts of interest among experts who will sit on an upcoming advisory panel reviewing peptide therapies. The staff memo warns that undiscl…
    raps · 1mo agoRegulatoryNegative↗ source
  • CDC links Taco Bell lettuce in five states to cyclospora outbreak
    Federal health officials have identified shredded iceberg lettuce from Mexico served at Taco Bell restaurants in Indiana, Kentucky, Michigan, Ohio and West Virginia as the source of a widespread cy…
    STAT · 1mo agoRegulatoryNegative↗ source
  • GSK discontinues its chronic cough therapy amid uncertain future
    GSK has announced that it is ending development of its chronic cough treatment. The decision marks the conclusion of the program that had been under investigation for several years. The article do…
    STAT · 1mo agoNegative↗ source
  • Sonothera touts ultrasound gene-delivery platform for Duchenne, but experts remain skeptical
    Sonothera, a California startup, says its ultrasound‑based technology can deliver therapeutic genes into cells, a method it believes could treat Duchenne muscular dystrophy and other genetic disord…
    STAT · 1mo agoNeutral↗ source
  • Opinion: MAHA pushes psychiatric deprescribing agenda, reshaping mental-health language
    Sunny Patel, an associate professor of psychiatry and pediatrics at Georgetown University, critiques the Mental Health Advocacy (MAHA) movement in a recent opinion piece. He notes her background wi…
    STAT · 1mo agoNegative↗ source
  • Ichnos Glenmark Innovation appoints Mariana Cota Stirner as chief medical officer
    Ichnos Glenmark Innovation announced the appointment of a new chief medical officer. Mariana Cota Stirner will assume the role, bringing experience from her recent position as fractional chief med…
    STAT · 1mo agoNeutral↗ source
  • Canadian wildfires drive NYC asthma ER visits up 31% as heat wave intensifies haze
    Recent Canadian wildfires have produced massive smoke plumes that have drifted into the United States, degrading air quality across many cities. In New York City, emergency department visits for a…
    STAT · 1mo agoNeutral↗ source
  • Trump administration moves to restore LGBTQ+ youth counseling on 988 line amid concerns over trans identity exclusion
    Specialized counseling services for LGBTQ+ youth are slated to return to the 988 Suicide & Crisis Lifeline by the end of the year, according to a recent confirmation from the Trump administration.…
    STAT · 1mo agoRegulatoryNegative↗ source
  • FDA approves Merck’s first oral PCSK9 inhibitor, marking a first for the drug class
    The U.S. Food and Drug Administration has granted approval to Merck for its oral PCSK9 inhibitor, the first drug of this type to receive such clearance. The approval represents a milestone because…
    STAT · 1mo agoApprovalPositive↗ source
  • Eli Lilly to buy psychedelics biotech AtaiBeckley for $2.8 billion
    Eli Lilly announced it will acquire AtaiBeckley, a biotech focused on psychedelic therapies for mental health, for an upfront cash payment of $2.8 billion. The purchase adds a new dimension to Lil…
    STAT · 1mo agoDealPositive↗ source
  • CDER plans new guidance on AI, electronic safety report submissions, and more
    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has updated its list of new and revised guidance documents it plans to issue this year to include four new…
    raps · 1mo agoApprovalPositive↗ source
  • UnitedHealth beats Q2 forecasts but warns rising insurance costs will strain employers
    UnitedHealth Group reported second-quarter results that exceeded analysts' expectations, lifting its shares modestly. Despite the upbeat earnings, executives highlighted that medical expenses for…
    STAT · 1mo agoEarningsNegative↗ source
  • Republicans block bill to end Medicare AI prior-authorization pilot
    A Senate vote on Thursday failed to halt a Medicare pilot that uses artificial intelligence to approve or deny care. The measure, backed by Democrats, was rejected by a 46‑to‑50 vote, with Republic…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Brain implant gives touch sensation back to man with quadriplegia
    Keith Thomas, a 48-year-old who lost feeling and movement below his neck after a diving accident in 2020, received a brain-computer interface implant in 2023 as part of an experimental study. The…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Medicare proposes overhaul of payment models for clinical AI and remote patient monitoring
    The Centers for Medicare and Medicaid Services (CMS) has announced a set of proposals aimed at reshaping how Medicare reimburses clinical artificial intelligence tools and remote patient monitoring…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Amylyx to read out pivotal endocrine drug study results later this quarter
    Amylyx Pharmaceuticals will read out results later this quarter from a study of a new treatment for a rare endocrine disorder. The drug, avexitide, is being developed to prevent severe, uncontroll…
    STAT · 1mo agoNeutral↗ source
  • CMS proposes new payment framework for clinical software and AI to link reimbursement with patient outcomes
    The Centers for Medicare & Medicaid Services (CMS) has released proposed rules for 2027 that would create a standardized payment structure for clinical software and artificial intelligence tools. T…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Stakeholders urge FDA to create drug-repurposing framework that avoids disincentives and stays within authority
    Stakeholders, including patients and healthcare industry groups, told the FDA that repurposing existing drugs offers significant opportunities for new treatments. They warned that any new repurpos…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Podcast highlights prediction markets entering biotech and Biogen Alzheimer's drug controversy
    The Readout LOUD episode released on July 16, 2026 features hosts Elaine Chen, Adam Feuerstein and Allison DeAngelis. The trio discuss trends shaping biotech, from new obesity treatments to evolvin…
    STAT · 1mo agoNeutral↗ source
  • Kalshi to Offer Prediction Market Bets on Clinical Trials and Regulatory Approvals
    Kalshi, one of the world’s largest prediction‑market exchanges, announced it will start allowing bets on the outcomes of clinical trials and regulatory approvals. The initiative could give investor…
    STAT · 1mo agoNeutral↗ source
  • Kalshi launches prediction markets for clinical trial results and FDA approvals
    Kalshi, a major prediction market exchange, announced it will begin offering markets that let participants bet on the outcomes of clinical trials and on whether drugs will receive FDA approval. Th…
    STAT · 1mo agoPositive↗ source
  • Venom’s hidden potential fuels next wave of peptide medicines beyond GLP-1 weight-loss drugs
    Steve Midway, an associate professor at LSU, argues that many powerful medicines already exist in the venoms of feared creatures, noting that venom contributed to the development of GLP-1 based wei…
    STAT · 1mo agoPositive↗ source
  • Medicaid and SNAP cuts deepen hunger and mental health crises, clinicians warn
    Cole Hanson, a clinical dietitian at a large urban hospital, writes about the direct link he sees between food insecurity and psychiatric emergencies. He recounts a patient who arrived with suicid…
    STAT · 1mo agoRegulatoryNegative↗ source