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3,686 stories matching this filter · ← front page

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  • Syntax Bio claims four-day stem-cell conversion into pancreatic beta cells
    Chicago-based Syntax Bio says its Cellgorithm platform can turn stem cells into pancreatic beta cells in as little as four days. The company describes the process as a programmable set of epigeneti…
    Fierce Biotech · 14d agoPositive readoutPositive↗ source
  • Artiva Biotherapeutics cuts 94% of workforce after patient deaths and failed autoimmune cell therapy
    Artiva Biotherapeutics announced it is halting development of its AlloNK natural killer cell therapy for autoimmune diseases and is laying off roughly 94% of its employees. The AlloNK product, an…
    Fierce Biotech · 14d agoLayoffsNegative↗ source
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  • Labcorp acquires Millennium Health to expand toxicology testing nationwide
    Labcorp announced it is buying Millennium Health, a specialty laboratory that provides toxicology tests for recent use of prescription medications and illicit drugs. The acquisition is intended to…
    Fierce Biotech · 14d agoDealPositive↗ source
  • FDA releases draft guidance on oversight of individualized gene-editing products
    The U.S. Food and Drug Administration issued draft guidance that outlines a proposed regulatory framework for individualized gene‑editing products, including cases where multiple product variants a…
    raps · 14d agoRegulatoryNeutral↗ source
  • FDA releases details on accelerated approval process for personalized gene therapies
    The U.S. Food and Drug Administration has issued additional guidance on a faster approval pathway designed for personalized gene therapies. The new details outline how sponsors can seek expedited r…
    STAT · 14d agoRegulatoryPositive↗ source
  • Alphabet’s GV tops biotech corporate investors with $5.23 billion in deals since 2025
    Alphabet’s venture arm GV has become the largest corporate spender in biotech, investing a cumulative $5.23 billion across 20 deals since the start of 2025. The total outlay exceeds the combined v…
    BioSpace · 14d agoNeutral↗ source
  • U.S. judge denies effort to block Eli Lilly's weight-loss ad; GSK reports oncology drug approval
    A U.S. district judge rejected a request to halt Eli Lilly's advertising campaign that Novo Nordisk alleges is deceptive in promoting its weight‑loss medicines. Novo Nordisk argued the ads could m…
    STAT · 14d agoRegulatoryNeutral↗ source
  • Pennsylvania Mennonite community creates its own biotech firm after successful gene therapy in a calf with maple syrup urine disease
    A tight‑knit Mennonite community in Lancaster County, Pennsylvania, has long faced a high rate of maple syrup urine disease (MSUD), a rare genetic disorder that can be fatal. With few external biot…
    STAT · 14d agoPositive↗ source
  • Aspen Neuroscience and Bambusa Therapeutics each target $134 million IPOs
    Aspen Neuroscience, a cell‑therapy company focused on Parkinson's disease, and Bambusa Therapeutics, a bispecific biotech, have filed SEC documents outlining plans for initial public offerings. Bo…
    Fierce Biotech · 14d agoDealNeutral↗ source
  • Leak of Moderna-Merck cancer vaccine phase 3 data sparks drama at ESMO 2026 conference
    The European Society for Medical Oncology (ESMO) meeting this year was marked by an unexpected leak of phase 3 results for a cancer vaccine being developed by Moderna and Merck. The data appeared t…
    Fierce Biotech · 14d agoNeutral↗ source
  • Missouri AG orders Eli Lilly to stop demanding hospital data for 340B discounts
    Missouri Attorney General Catherine Hanaway sent a cease‑and‑desist letter to Eli Lilly on Oct 26, demanding the company stop requiring hospitals to submit claims data as a condition for receiving…
    STAT · 14d agoRegulatoryNegative↗ source
  • Nonprofit revives gene therapy program after UK startup closure
    Bloomsbury Genetic Therapies, a U.K.-based gene‑therapy startup, announced it was shutting its doors after treating only a single patient. The company’s closure left its lead experimental therapy w…
    STAT · 14d agoPositive↗ source
  • Researchers isolate marine compound that may halt deadly brain-eating amoeba infections
    Brain-eating amoebas are notoriously difficult to treat and have a mortality rate that is almost 100%. The article notes that researchers have now isolated a compound from the sea that could potent…
    STAT · 14d agoPositive↗ source
  • Pediatric emergency departments remain in chronic crisis after 2022 tripledemic, says opinion piece
    The authors argue that the surge in pediatric patients that peaked in 2022 has become a routine reality, leaving emergency departments across the country in a state of permanent crisis. A rural ho…
    STAT · 14d agoNegative↗ source
  • FDA approves prostate cancer and Crohn’s disease therapies as judge rejects effort to block Lilly weight‑loss ads
    The U.S. Food and Drug Administration announced approvals for new treatments targeting prostate cancer and Crohn’s disease. The decisions expand therapeutic options for patients with these conditio…
    raps · 14d agoRegulatoryNeutral↗ source
  • RFK Jr. campaigns in Iowa as healthcare companies prepare earnings reports
    Robert F. Kennedy Jr. appeared in Iowa to support GOP gubernatorial candidate Zach Lahn, marking his final push on the campaign trail. The week’s agenda also includes earnings calls from major hea…
    STAT · 14d agoNeutral↗ source
  • FDA officials share guidance on de novo device classifications and upcoming MDUFA VI changes at MedTech Conference
    At the MedTech Conference in Boston, FDA officials and industry experts discussed de novo classification requests. They offered practical tips for companies seeking de novo designation, stressing…
    raps · 14d agoRegulatoryNeutral↗ source
  • Taylor Farms recalls H-EB Backyard BBQ Chop Salad Kit over possible undeclared soy and almonds
    Taylor Farms of Dallas, Texas announced a recall of the H-EB Backyard BBQ Chop Salad Kit because the product may contain undeclared soy and tree nuts (almonds). The kits were distributed to H-EB…
    fda recalls · 14d agoCRLNegative↗ source
  • Haifa Smoked Fish recalls 560 lbs of cold-smoked sprats over possible Clostridium botulinum contamination
    Haifa Smoked Fish of Queens, NY announced a recall of about 560 pounds of its cold-smoked sprats after testing indicated possible contamination with Clostridium botulinum, a bacterium that can caus…
    fda recalls · 14d agoRegulatoryNegative↗ source
  • STAT+: After two deaths in autoimmune cell therapy trial, Artiva is shutting down
    Recent deaths are setbacks in drug companies’ interest in applying cancer therapy strategies to autoimmune diseases.
    STAT · 14d ago↗ source
  • After 2 patient deaths and cell therapy durability concerns, Artiva cuts 94% of workforce
    Artiva Biotherapeutics, which had been evaluating cell therapy AlloNK for the treatment of rheumatoid arthritis and other autoimmune diseases, is exploring strategic options that could include diss…
    BioSpace · 14d ago↗ source
  • Roche's KRAS inhibitor divarasib shows strong results in second-line lung cancer trial at ESMO
    Roche presented data from a trial of its KRAS G12C inhibitor divarasib at the European Society for Medical Oncology meeting. The study evaluated divarasib in patients with advanced non-small cell…
    STAT · 15d agoPositive readoutPositive↗ source
  • Amgen’s Imdelltra plus AstraZeneca’s Imfinzi cuts death risk by ~60% in extensive-stage small cell lung cancer
    Amgen presented Phase 3 data at ESMO 2026 showing that its bispecific T‑cell engager Imdelltra, when added to AstraZeneca’s checkpoint inhibitor Imfinzi, significantly reduced mortality in extensiv…
    BioSpace · 15d agoPositive readoutPositive↗ source
  • Moderna and Merck aim to file personalized cancer vaccine for FDA approval after Phase 3 success
    Moderna CEO Stéphane Bancel said the company’s personalized cancer vaccine, intismeran, met its primary goals in a pivotal Phase 3 trial. The success was disclosed during an interview at the ESMO m…
    STAT · 15d agoPositive readoutPositive↗ source
  • Merck/Kelun ADC sac-TMT cuts death risk by one-third in advanced endometrial cancer
    A randomized Phase 3 trial showed that the antibody‑drug conjugate sacituzumab tirumotecan (sac‑TMT) reduced the risk of death by about one‑third in patients with advanced endometrial cancer. The…
    STAT · 15d agoPositive readoutPositive↗ source