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  • Moderna and Merck report success for personalized mRNA vaccine in late-stage melanoma trial
    Moderna and Merck announced that their personalized mRNA cancer vaccine succeeded in a late-stage melanoma study. The vaccine, called intismeran, was evaluated in a randomized Phase 3 trial, the fi…
    STAT · 2mo agoPositive readoutPositive↗ source
  • B. Braun voluntarily recalls one lot of Excel Lactated Ringers IV solution over particulate contamination
    B. Braun Medical Inc announced a voluntary recall of a specific lot of its Excel Lactated Ringers Injection, a 1000 mL IV solution, after detecting particulate matter in the product. Laboratory an…
    fda recalls · 2mo agoCRLNegative↗ source
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  • Trump administration nominates Heidi Overton as FDA commissioner
    President Donald Trump has nominated Heidi Overton, the White House deputy director of domestic policy, to serve as the next commissioner of the Food and Drug Administration. Overton has been desc…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Trump administration expected to nominate White House policy aide Heidi Overton as FDA commissioner
    President Donald Trump is expected to put forward White House deputy director of domestic policy Heidi Overton as the next commissioner of the U.S. Food and Drug Administration, according to STAT.…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Trump nominates White House aide Heidi Overton as FDA commissioner
    President Donald Trump announced his intent to nominate Heidi Overton, M.D., Ph.D., a current White House aide, to lead the Food and Drug Administration. Overton earned her medical degree from the…
    Fierce Biotech · 2mo agoRegulatoryNeutral↗ source
  • Tolerance Bio secures up to $260 M for thymus‑targeting fusion protein, moves into Phase 2 trials
    Tolerance Bio, a Philadelphia biotech founded in October 2024, has signed a licensing agreement to acquire rights to NeoImmuneTech’s long‑acting IL‑7 fusion protein, efineptakin alfa, for up to $26…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • AI fuels a parallel, unregulated medical ecosystem outside traditional care
    Arya Rao, a Harvard‑MIT M.D.-Ph.D. candidate, and Marc Succi, a Harvard radiology professor, argue that financial incentives are pulling major AI firms into health care, creating a shadow system se…
    STAT · 2mo agoNegative↗ source
  • Accrediting body weighs dropping explicit racism language from public health curriculum standards
    The Council on Education for Public Health is reviewing its core competency language for accredited schools. Currently the standards require students to discuss how structural bias, social inequit…
    STAT · 2mo agoRegulatoryNegative↗ source
  • New CDC Director Erica Schwartz vows to speak truth to power and champion transparency
    In an all-hands meeting recorded by STAT, Erica Schwartz, the newly appointed director of the Centers for Disease Control and Prevention, told staff she is very comfortable and very confident in sp…
    STAT · 2mo agoRegulatoryPositive↗ source
  • Merck partners with Sarah Cannon to accelerate community oncology trials
    Merck & Co. has entered a collaboration with the Sarah Cannon Research Institute to expand patient access to oncology trials at community sites across the United States. The partnership will use S…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Biotech and Academia Explore New Partnership Models to Boost Drug Development
    The article notes that declining alternative funding and a drop in research grants are forcing biotech companies and universities to rethink how they collaborate. At the 2026 Chief Medical Officer…
    Fierce Biotech · 2mo agoPositive↗ source
  • Emerging Biotechs Can Speed Development with Tailored Global Trial Strategies, Panel Says
    A panel of biotech chief medical officers and CRO executives discussed how small biotechs can accelerate clinical development by using fit-for-purpose global trial designs. They highlighted both t…
    Fierce Biotech · 2mo agoNeutral↗ source
  • Experts split over Huidagene’s gene-editing approach after boy’s death in Duchenne trial
    A young boy died while participating in Huidagene’s gene‑editing trial for Duchenne muscular dystrophy, raising serious questions about the company’s experimental strategy. STAT+ reviewed video of…
    STAT · 2mo agoNegative↗ source
  • Trump expected to nominate White House adviser Heidi Overton as FDA commissioner
    President Trump is expected to select Heidi Overton, a physician and deputy director of domestic policy, to become the next commissioner of the Food and Drug Administration. Overton has been a pro…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Long-term brain organoids survive over five years and develop molecular features of human brains
    Researchers at Harvard have kept brain organoids alive for more than five years, observing continued growth and maturation that mirrors human brain development. The long-term cultures displayed mo…
    STAT · 2mo agoPositive↗ source
  • Pharma execs discuss how to evaluate biotech partners and acquisition targets
    A recent CMO Summit 360° webcast brought together biotech chief medical officers and pharma representatives to talk about how pharma teams assess biotech companies for partnerships or acquisitions.…
    Fierce Biotech · 2mo agoNeutral↗ source
  • Pediatrician warns AI chatbots may expose children to sexual content
    A pediatrician recounts a recent visit where a father reported alarming alerts on his home router showing sexual content that appeared to come from an AI chatbot on his 12-year-old daughter's lapto…
    STAT · 2mo agoNegative↗ source
  • Physician group sues HHS and USDA over alleged secret panel in dietary guideline rewrite
    A physician advocacy group has filed a federal lawsuit challenging the Trump administration's handling of the 2026 dietary guidelines. The Plaintiffs, the Physicians Committee for Responsible Medi…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Amgen ends $500M Crohn’s disease collaboration with TScan, but TScan says pipeline strategy stays on track
    Amgen has terminated its collaboration with TScan Therapeutics that was aimed at Crohn’s disease, ending a deal that could have delivered up to $500 million in milestones. The partnership began in…
    Fierce Biotech · 2mo agoDealNeutral↗ source
  • American Cancer Society cancels long-running alcohol industry gala amid optics concerns
    The American Cancer Society announced it will not hold its annual Wine and Spirits Industry Gala that was scheduled for October at the Rainbow Room in Manhattan. The gala had been a major fundrais…
    STAT · 2mo agoNeutral↗ source
  • STAT launches trust-in-science reporter and editor roles to strengthen scientific coverage
    STAT reflects on its founding mission of trusted journalism and how the COVID-19 pandemic highlighted the need for reliable science reporting. The outlet notes a broader crisis of trust in science…
    STAT · 2mo agoPositive↗ source
  • Optimal Balance Pharmacy recalls one lot of compounded glutathione injection over high endotoxin levels
    Optimal Balance Pharmacy announced a voluntary recall of a single lot of its compounded glutathione 200 mg/mL multi‑dose vials. The recall was triggered after internal testing detected elevated bac…
    fda recalls · 2mo agoCRLNegative↗ source
  • Epic’s annual meeting offers limited AI updates, highlights new customers and quirky song choices
    At Epic’s annual meeting, the company touched on artificial intelligence but provided few concrete details about its strategy or new tools. During the session, Epic staff announced a roster of new…
    STAT · 2mo agoNeutral↗ source
  • Prince Bakery recalls several breads over undeclared milk and sesame allergens
    Prince Bakery Inc. of Bronx, New York announced a recall of multiple Prince brand breads because they may contain undeclared milk or sesame. The recall covers Sesame Italian Bread, Large Italian B…
    fda recalls · 2mo agoRegulatoryNegative↗ source
  • Immunologist Liz Marnik, raised unvaccinated, now advocates for science and empathy in vaccine discussions
    Immunologist Liz Marnik grew up in a household that rejected vaccines, and she herself went without any immunizations into adulthood. At age 23 she visited a travel clinic and received all standar…
    STAT · 2mo agoPositive↗ source