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2,206 stories matching this filter · ← front page

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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 · 3mo 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 · 3mo agoRegulatoryPositive↗ source
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  • Create Medicines secures $122M Series B to advance in vivo CAR-T therapies
    Create Medicines, a Cambridge biotech, announced a $122 million Series B financing to expand its in vivo CAR-T cell therapy platform targeting cancer and autoimmune diseases. The round was co-led…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoRegulatoryNeutral↗ source
  • Biogen pushing tau drug forward despite Alzheimer’s study failure
    One of the company’s more closely watched research assets, BIIB080 is now heading to late-stage testing based on “the strength of the biomarker and efficacy data” seen in a Phase 2 trial.
    BioPharma Dive · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoNegative↗ source
  • FDA leadership gap deepens uncertainty for biotech as acting officials take charge
    Marty Makary's resignation as FDA commissioner has left the agency without a permanent head. Kyle Diamantas is serving as the temporary leader, while three senior drug-review positions are filled b…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • Lilly data show lower-dose GLP-1 injections and oral pill help sustain weight loss
    Eli Lilly presented new research on how patients who have lost weight with GLP‑1 medicines can maintain that loss over time. The studies followed people who had achieved significant reductions usin…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Assertio rejects Garda bid, accepts Zydus offer valuing company at $23.50 per share
    Assertio Holdings announced it has terminated its pending acquisition by Garda Therapeutics after the board approved a higher offer from another suitor. The new proposal from Zydus Worldwide value…
    BioPharma Dive · 3mo agoDealNeutral↗ 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 · 3mo 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 · 3mo 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 · 3mo agoNegative↗ source
  • Podcast Highlights Community Oncology’s Growing Role in U.S. Cancer Care
    A new sponsored podcast episode explores how community oncology clinics are becoming a vital part of the U.S. cancer‑care landscape. The program, released in May 2026, discusses why these local cen…
    BioPharma Dive · 3mo agoPositive↗ source