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508 stories matching this filter · ← front page

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  • Ionis shares tumble over $1 billion as Tryngolza sales forecast cut in half
    Ionis Pharmaceuticals saw its market value drop by more than $1 billion after it lowered its sales outlook for Tryngolza, a triglyceride‑lowering therapy. The company now expects $50 million in sa…
    STAT · 21h agoNegative↗ source
  • Oura to buy AI health chatbot firm Counsel Health for $625 million
    Oura announced that it will acquire Counsel Health, a startup that builds clinical artificial‑intelligence tools, for a cash price of $625 million. Counsel Health operates a conversational chatbot…
    STAT · 4h agoDealPositive↗ source
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  • FDA approves Bayer's Sunharbo, a new class drug to lower stroke recurrence
    The FDA has given its nod to a Bayer medication designed to cut the risk of another stroke in patients who have already suffered one. The product, marketed as Sunharbo, belongs to a newly created…
    STAT · 7h agoApprovalPositive↗ source
  • PepGen reports promising early results for myotonic dystrophy type 1 drug in six-patient trial
    PepGen announced that its experimental therapy for myotonic dystrophy type 1 showed the most encouraging early data yet in a small study. The trial involved six patients who received the drug for 1…
    STAT · 9h agoPositive readoutPositive↗ source
  • STAT+: GLP-1s are given an FDA warning for rare eye condition risk
    The FDA warned that GLP-1 drugs carry a potential risk of a rare but serious eye condition sometimes referred to as an “eye stroke.”
    STAT · 7h ago↗ source
  • FDA approves Bayer’s Sunharbo, first Factor XIa inhibitor to lower stroke recurrence risk
    The Food and Drug Administration has approved Bayer's new medication intended to prevent another stroke in patients who have already experienced one. The drug, sold under the brand name Sunharbo,…
    STAT · 23h agoApprovalPositive↗ source
  • FDA warns GLP-1 weight-loss drugs may cause rare eye stroke condition
    The Food and Drug Administration issued a warning that GLP-1 drugs used for weight loss may be linked to a rare eye condition called non-arteritic anterior ischemic optic neuropathy, sometimes desc…
    STAT · 1d agoRegulatoryNegative↗ source
  • Global liver experts agree on definition of acute-on-chronic liver failure
    Liver doctors from many countries have reached a common definition for acute-on-chronic liver failure, a serious complication that occurs when an existing liver disease is suddenly worsened by an a…
    STAT · 1d agoPositive↗ source
  • American Heart Association meeting reports neutral outcomes for inflammation and Lp(a) trials
    The American Heart Association's scientific sessions in Chicago highlighted a theme of neutral findings across cardiovascular research. Two high profile trials, ZEUS targeting inflammation and HOR…
    STAT · 1d agoNeutral↗ source
  • New evidence links AAV gene therapies to tumor risk, raising safety concerns
    Recent cases reported this year provide strong evidence that adeno-associated viruses (AAVs), the vectors used to deliver therapeutic genes, can trigger tumor formation. The findings settle a two‑d…
    STAT · 4d agoRegulatoryNegative↗ source
  • Novartis reports seven new tumor cases in children treated with Zolgensma gene therapy
    Novartis has disclosed that seven children who received its SMA gene therapy, Zolgensma, have been found to have tumors that were not previously reported. The cases were brought to light by an adv…
    STAT · 5d agoRegulatoryNegative↗ source
  • Sickle cell gene-editing therapy shows signs of revival as developers revisit trial after earlier safety halt
    A recent STAT+ article highlights that a sickle cell gene‑editing therapy, whose trial was stopped three years ago after a serious adverse event in the first patient, may be making a comeback. The…
    STAT · 5d agoNeutral↗ source
  • Democrats’ midterm sweep positions Bernie Sanders to steer Senate health committee, raising hopes for major FDA reforms
    The recent midterm elections delivered a decisive victory for Democrats, giving the party control of Congress and setting the stage for sweeping health‑care changes. Among the anticipated shifts,…
    STAT · 5d agoRegulatoryNeutral↗ source
  • China clamps down on investigator-initiated biotech trials after patient deaths, halting rare-disease studies
    Chinese regulators have introduced new rules that sharply limit investigator‑initiated biotech trials after a series of patient deaths were reported this summer. The policy shift is intended to tig…
    STAT · 5d agoRegulatoryNegative↗ source
  • MDCG issues guidance on clinical evidence for orphan in-vitro diagnostics
    The Medical Device Coordination Group (MDCG) has published new guidance that explains how clinical evidence requirements apply to orphan in-vitro diagnostics (IVDs). The document is intended to he…
    raps · 5d agoRegulatoryNeutral↗ source
  • Ballot measures on abortion, marijuana and transgender youth care highlight political divides in 2026 midterms
    Voters in the 2026 midterm elections faced a slate of state health policy ballot measures that addressed abortion rights, marijuana legalization, science funding bonds and care for transgender yout…
    STAT · 5d agoNeutral↗ source
  • STAT+: Novartis cites cases of previously unknown tumors possibly tied to its SMA gene therapy
    Novartis has acknowledged seven previously unknown instances in which tumors were found in children who were treated with its spinal muscular atrophy therapy, Zolgensma.
    STAT · 5d ago↗ source
  • Ultragenyx to lay off roughly 20% of staff as it halts two rare disease drug programs
    Ultragenyx announced it will cut about 20% of its workforce as it ends development of two rare disease drug candidates. The move follows a recent clinical study that failed to meet its primary end…
    STAT · 6d agoLayoffsNegative↗ source
  • CVS Health to split into two separate companies, separating insurance and pharmacy operations
    CVS Health announced that it will divide the business into two independent companies. One entity will house its insurance arm Aetna together with pharmacy‑benefit manager Caremark, while the other…
    STAT · 6d agoDealNeutral↗ source
  • Servier’s $1.55 billion Becker muscular dystrophy drug fails pivotal Phase 3 trial
    Servier announced that its experimental drug for Becker muscular dystrophy did not meet its primary endpoint in a Phase 3 trial called GRAND CANYON. The drug, sevasemten, was acquired from Edgewis…
    STAT · 7d agoNegative readoutNegative↗ source
  • Scientists question safety and benefits of three-parent IVF as new UK data raise concerns
    The mitochondrial replacement technique, often called three‑parent IVF, was hailed after the United Kingdom reported the birth of eight healthy children whose mothers carried disease‑causing mitoch…
    STAT · 7d agoRegulatoryNegative↗ source
  • FDA issues final guidance on potency assurance for cell and gene therapy manufacturers
    The FDA released final guidance today outlining a science- and risk-based Potency Assurance Strategy for cellular and gene therapy (CGT) products. The guidance replaces the agency’s 2011 potency t…
    fda press · 8d agoRegulatoryNeutral↗ source
  • 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
  • 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
  • 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