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  • Eugia US LLC (f/k/a Auro Medics Pharma LLC) Issues Voluntary Nationwide Recall of Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (Single Dose Vial) Due to Presence of Particulate Matter
    FOR IMMEDIATE RELEASE –November 06,2026 – East Windsor, New Jersey, Eugia US LLC (f/k/a Auro Medics Pharma LLC) is voluntarily recalling lot number 3VM26026A of Vancomycin Hydrochloride for Injecti…
    fda recalls · 3d ago↗ source
  • FDA grants accelerated approval for Rybrevant Faspro in recurrent/metastatic head and neck cancer
    The U.S. Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carci…
    fda press · 3d agoApprovalPositive↗ source
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Nephrology753
  • 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 · 3d agoRegulatoryNegative↗ source
  • Revolution Medicines' Rasonque generates $198 million in sales within five weeks of U.S. approval
    Revolution Medicines reported that its pancreatic cancer therapy Rasonque has achieved $198 million in revenue in the first five weeks after receiving U.S. approval. The company said more than 5,00…
    STAT · 4d agoApprovalPositive↗ source
  • MIT defamation verdict awards $6 million to former star scientist, sparking campus debate over harassment claims
    A Boston jury awarded former MIT biologist David Sabatini $6 million in a defamation case against former colleague Kristin Knouse, a biology professor at the institute. The judgment stems from a la…
    STAT · 3d agoNegative↗ 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 · 4d agoNeutral↗ source
  • RevMed stock rises on early Rasonque sales as whistleblower sues Madrigal over MASH safety
    RevMed announced its first sales figures for Rasonque, a therapy targeting pancreatic cancer, and the news sent the company's shares higher. The company said the early sales data reflect market up…
    Endpoints · 4d agoNeutral↗ source
  • Caldera and Evommune secure China licensing agreements for autoimmune drug assets
    Caldera and Evommune announced they have entered licensing agreements with Chinese partners to bring their autoimmune drug programs to the Chinese market. The deals come as the biopharma sector is…
    Endpoints · 4d agoDealPositive↗ source
  • Merck reports positive mid-stage results for Hanmi-licensed MASH drug
    Merck announced Thursday that its dual GLP-1/glucagon agonist, which it licensed from South Korea’s Hanmi Pharmaceutical in 2020, has met its primary endpoints in a mid-stage trial for metabolic dy…
    Endpoints · 4d agoPositive readoutPositive↗ source
  • India proposes rule to instantly suspend drug manufacturing licenses that fail government quality tests
    India’s regulators have drafted new rules that would require an immediate suspension of any drug manufacturing license if the product does not meet quality standards in government testing. The prop…
    STAT · 4d agoRegulatoryNeutral↗ 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 · 4d 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 · 4d agoRegulatoryNegative↗ source
  • Alethio Therapeutics raises $90 million Series A to develop antibody for essential thrombocythemia
    Alethio Therapeutics, a spinout from the University of Oxford, announced a $90 million Series A financing round. The capital will fund the company’s lead program, an antibody designed to treat ess…
    Endpoints · 4d agoDealPositive↗ source
  • T-Therapeutics raises $133 million from Sanofi, J&J, Merck KGaA and Eli Lilly for TCR cancer and autoimmune programs
    T-Therapeutics, a UK biotech focused on T-cell receptor therapies for cancer and autoimmune diseases, announced it has raised $133 million in financing. The round is led by Sanofi with participati…
    Endpoints · 4d agoDealPositive↗ source
  • PhRMA spent roughly $59 million on search ads to shape public views on drug pricing
    PhRMA, the trade group for U.S. drug makers, spent about $59 million on search advertising over a recent seven‑year period to influence how Americans perceive prescription‑drug costs. Roughly $32…
    STAT · 3d agoNeutral↗ source
  • New treatments for preeclampsia move closer to patients
    Emily Chaddock’s experience highlights the danger of severe preeclampsia, a pregnancy complication that can threaten both mother and baby. At 27 weeks she developed the condition, leading to a rapi…
    Endpoints · 3d agoPositive↗ source
  • Democratic doctors celebrate gains as MAHA’s future remains uncertain after election
    The STAT+ D.C. Diagnosis newsletter reports that doctors aligned with the Democratic Party secured notable wins in recent political battles. At the same time, the Medicare for All (MAHA) initiativ…
    STAT · 4d agoNeutral↗ source
  • ProMis shares tumble after competitor's Alzheimer trial failure, CEO calls reaction overblown
    ProMis Neurosciences, developer of an amyloid‑targeting Alzheimer’s therapy, saw its stock plunge sharply last week. The decline came after Acumen Pharmaceuticals announced that its own amyloid‑ta…
    STAT · 4d agoNegative↗ source
  • Health systems grapple with AI chatbot use, some block tools while others consider in-house solutions
    Free AI chatbots designed for clinicians, such as OpenEvidence, Doximity Ask and ChatGPT for Clinicians, have become popular, with hundreds of thousands of doctors turning to them for clinical guid…
    STAT · 4d agoRegulatoryNeutral↗ source
  • AAFP chief urges Congress to add oversight to CDC vaccine advisory panel
    Shawn Martin, CEO of the American Academy of Family Physicians, said the CDC’s Advisory Committee on Immunization Practices (ACIP) has faced more than a year of turmoil. He is urging Congress to e…
    Endpoints · 3d agoRegulatoryNeutral↗ source
  • STAT+: Beyond statins, one drug lowered heart attack risk by 20%
    A new study could help doctors figure out what medicine to prescribe for cholesterol when statins don't cut it: It's “answering a really challenging clinical question."
    STAT · 4d agoRegulatoryNeutral↗ source
  • Trump administration ends contracts with two No Surprises Act arbitrators over performance failures
    The federal government announced that two organizations that handle disputes under the No Surprises Act will no longer be allowed to accept new cases, saying they failed to meet required performanc…
    STAT · 3d agoRegulatoryNegative↗ source
  • Ellipsis Health acquires Kouper Health to expand AI voice call capabilities
    Ellipsis Health, a startup that builds voice-based artificial intelligence tools for healthcare, announced it has purchased Kouper Health. The deal reflects growing interest in AI systems that can…
    Endpoints · 4d agoDealNeutral↗ source
  • Medicare postpones controversial rule that bars hospitals from using third-party remote patient monitoring services
    Medicare announced it will finalize a proposal that delays an update to its remote patient monitoring (RPM) rule, despite strong opposition. The rule would prohibit hospitals and other providers f…
    STAT · 4d agoRegulatoryNegative↗ 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 · 3d agoNeutral↗ source