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  • Regenxbio reports successful Duchenne gene therapy trial, clearing path to FDA filing
    Regenxbio announced that its experimental gene therapy for Duchenne muscular dystrophy met its primary endpoints in a recent clinical trial, producing sufficient levels of a truncated muscle protei…
    STAT · 6mo agoPositive readoutPositive↗ source
  • Supreme Court blocks restrictions, keeps mifepristone available through pharmacies and mail
    Supreme Court on Thursday issued an order that maintains women's ability to obtain the abortion medication mifepristone without requiring an in-person doctor visit. The decision overturns a lower-…
    STAT · 6mo agoRegulatoryPositive↗ source
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  • Biogen advances tau-targeting Alzheimer drug to Phase 3 despite mixed Phase 2 data
    Biogen reported results from a Phase 2 trial of its tau-targeting Alzheimer’s candidate diranersen (BIIB080). The study measured tau levels in cerebrospinal fluid and brain tissue of patients with…
    STAT · 6mo agoPositive readoutPositive↗ source
  • FDA commissioner Marty Makary exits, acting head Kyle Diamantas named as podcast discusses impact and Senate health race
    The Readout Loud podcast episode focused on health politics, featuring a discussion of FDA commissioner Marty Makary's departure. Hosts examined why Makary is leaving, which of his policies might…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • Biogen reports mixed results in mid‑stage trial of tau‑targeting Alzheimer’s therapy
    Biogen disclosed data from a Phase 2 study of its experimental Alzheimer’s drug that targets the tau protein. The trial showed a combination of positive and negative signals, with some measures ind…
    STAT · 6mo agoNegative readoutNeutral↗ source
  • CREATE Medicines raises $122 million to advance CAR-T candidates into human trials
    CREATE Medicines, formerly Myeloid Therapeutics, announced a $122 million financing round. The funding came from Newpath Partners, ARCH Venture Partners, Hatteras Venture Partners and other invest…
    STAT · 6mo agoDealPositive↗ source
  • Acting FDA Commissioner Kyle Diamantas Seen as Drama-Free Stabilizer for Biotech
    Kyle Diamantas has been named the acting commissioner of the Food and Drug Administration, stepping into the role after Marty Makary’s resignation. He previously led the FDA’s food safety division,…
    STAT · 6mo agoRegulatoryPositive↗ source
  • FDA searches for new commissioner as Marty Makary departs, Trump administration outlines priorities
    Marty Makary is leaving his role at the FDA, as reported in STAT’s D.C. Diagnosis newsletter. The Trump administration has released a lengthy wish list for the next FDA commissioner, indicating th…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • STAT launches investigative series on alcohol epidemic killing 178,000 Americans annually
    STAT has begun a new investigative series that examines the United States’ ongoing alcohol crisis, which the outlet says results in roughly 178,000 deaths each year. The reporting team traveled na…
    STAT · 6mo agoNegative↗ source
  • STAT+: CDC plans to transfer monkeys to nonprofit’s sanctuary as it seeks to reduce animal testing
    The CDC intends to transfer more than 160 macaques to Born Free USA, a nonprofit that runs a large primate sanctuary in Texas, as the agency seeks to phase out…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • Major digital health firms stay out of Medicare's chronic care ACCESS pilot
    The latest STAT Health Tech newsletter reports that the biggest players in digital health are not participating in Medicare's ACCESS pilot, a program designed to test chronic-care solutions for Med…
    STAT · 6mo agoNeutral↗ source
  • Alcohol treatment sees growing shift toward alternatives beyond Alcoholics Anonymous
    The article highlights a growing movement away from traditional Alcoholics Anonymous programs toward newer, more flexible approaches for treating alcohol use disorder. It notes that many patients a…
    STAT · 6mo agoNeutral↗ source
  • Three years of falling overdose deaths spark cautious optimism amid lingering concerns
    Over the past three years, the United States has seen a steady decline in overdose deaths, a trend that has generated cautious optimism among public‑health observers. While the numbers are encourag…
    STAT · 6mo agoPositive↗ source
  • Physician warns AI could undermine authentic care in addiction treatment
    Physician Steve D. Klein, an addiction medicine specialist, argues that recent AI tools marketed for addiction care miss the core of patient treatment. He describes seeing a prototype that, while t…
    STAT · 6mo agoNegative↗ source
  • MIT reports 10% drop in research output and 20% fall in graduate admissions amid funding and immigration challenges
    MIT President Sally Kornbluth announced that the institute's research enterprise is 10% smaller than a year ago. The university also said graduate admissions for the 2026-2027 year are down 20%, c…
    STAT · 6mo agoNegative↗ source
  • MetALD emerges as a growing U.S. liver crisis linked to obesity, diabetes and heavy drinking, hitting young adults and women
    U.S. doctors are naming a new liver condition, MetALD, that combines metabolic dysfunction with alcohol related damage. The syndrome reflects the overlap of obesity, diabetes and heavy drinking tha…
    STAT · 6mo agoNegative↗ source
  • Trump administration seeks new FDA commissioner to restore trust, prioritize food policy and accelerate drug approvals
    The Trump administration is moving quickly to name a successor to FDA commissioner Marty Makary, who resigned. Officials say the search will take several weeks and they are looking for a leader wh…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • U.S. overdose deaths drop 14% in 2025, marking third consecutive yearly decline
    Preliminary CDC data show about 70,000 overdose deaths in 2025, roughly 14% fewer than in 2024 and similar to 2019 levels before the pandemic. The decline was observed across major drug categories…
    STAT · 6mo agoPositive↗ source
  • Gene therapy viral vectors implicated in a child’s tumor, raising safety concerns
    A recent STAT+ report highlights a case where viral vectors used in gene therapy were found to be associated with a tumor in a young boy. The article notes that investigators have identified a poss…
    STAT · 6mo agoNegative↗ source
  • Safety-boosting drug may weaken gene therapy efficacy in Dravet syndrome trial
    Encoded Therapeutics studied a drug meant to improve the safety of gene therapy in children with Dravet syndrome, a severe genetic epilepsy. In the trial of 21 participants, most received steroids…
    STAT · 6mo agoNegative readoutNegative↗ source
  • Doctors link infant's brain tumor to gene therapy virus in rare case
    Doctors treated 13-month-old Adam with an experimental gene therapy after his stem cell transplant failed, and the boy subsequently reached developmental milestones such as learning sign language a…
    STAT · 6mo agoNeutral↗ source
  • DOJ subpoenas signal start of criminal probe into gender-affirming care for minors
    Several hospitals have been served with grand jury subpoenas that request information about gender‑affirming treatments provided to minors, indicating that the Justice Department has opened a crimi…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • FDA Commissioner Marty Makary resigns, Kyle Diamantas named acting commissioner
    The U.S. Food and Drug Administration announced that Commissioner Marty Makary will step down from his position. The agency said that Kyle Diamantas, who currently oversees food regulation, will se…
    STAT · 6mo agoRegulatoryNeutral↗ source
  • Lack of Affordable Air Conditioning Poses Fatal Risk for Diabetes Patients, Experts Warn
    The opinion piece by Charles Leonard and Anthony Nicome argues that access to air conditioning should be treated as essential preventive care for people with chronic illnesses, especially diabetes,…
    STAT · 6mo agoNegative↗ source
  • Trump admin defers $1.3 billion in Medicaid payments to California over fraud concerns
    Vice President JD Vance announced that the federal government will hold back $1.3 billion in Medicaid reimbursements to California while investigations into alleged fraud continue. The move is part…
    STAT · 6mo agoRegulatoryNegative↗ source