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  • 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 · 13d agoNegative↗ source
  • FDA issues early alert on B. Braun Streamline Bloodline Set recall due to connector leak risk
    The FDA's Center for Devices and Radiological Health issued an Early Alert about B. Braun's Streamline Bloodline Set for Dialog+ after discovering a potential high risk issue. The problem is trace…
    fda medwatch · 14d agoCRLNegative↗ source
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  • 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
  • U.S. judge rejects Novo Nordisk's bid to block Eli Lilly obesity drug ads
    A U.S. federal judge denied Novo Nordisk's request to halt television advertisements by Eli Lilly for its obesity treatments. Novo had argued the ads were misleading and sought an injunction, but…
    Endpoints · 13d agoRegulatoryNegative↗ source
  • Anthropic acquires one-person biotech Mithril Medicine to expand into life sciences
    Anthropic, known for its artificial intelligence work, announced it has purchased Mithril Medicine, a drug discovery startup run by a single individual. The deal is presented as a step in Anthropi…
    Endpoints · 13d agoDealNeutral↗ source
  • Mennonite family backs new gene-therapy startup
    A new gene‑therapy company is taking shape with financial support from members of the Amish and Mennonite communities. The story highlights the unusual partnership between a traditional religious g…
    Endpoints · 13d agoDealNeutral↗ source
  • Outpace Bio halts Phase 1 ovarian cancer CAR‑T trial
    Outpace Bio announced that it has stopped its Phase 1 trial of OPB-101, an autologous CAR‑T therapy targeting mesothelin in ovarian cancer. The company said the trial will no longer enroll patient…
    Endpoints · 13d agoNegative readoutNegative↗ 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 · 13d 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
  • 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 · 13d 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 · 14d 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 · 14d 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 · 14d agoPositive readoutPositive↗ source
  • GSK gains another cancer drug approval and unveils promising chemo data as it prepares for lung cancer approval
    GSK received regulatory approval this week for one of its cancer medicines in an additional tumor indication, expanding the portfolio that has grown since the company re-entered oncology a decade a…
    STAT · 14d agoApprovalPositive↗ source
  • Incyte reports lasting tumor responses in pancreatic cancer patients using targeted drug plus chemotherapy
    Incyte announced at the European Society for Medical Oncology meeting that its targeted therapy, when combined with standard chemotherapy, produced durable tumor responses in a subset of pancreatic…
    STAT · 14d agoPositive readoutPositive↗ source
  • Moderna CEO Bancel optimistic after Phase 3 success of mRNA melanoma vaccine intismeran
    Moderna chief executive Stéphane Bancel said the company will move quickly to obtain FDA approval for its experimental melanoma therapy intismeran after a Phase 3 trial showed positive results. Th…
    STAT · 14d agoPositive readoutPositive↗ source
  • Bon Secours Mercy Health to Acquire Surgery Partners in $5.7 B Deal, Expanding Ambulatory Surgery Network
    Nonprofit Bon Secours Mercy Health announced it will buy Surgery Partners, a publicly traded operator of more than 200 ambulatory surgery centers, short-stay hospitals and physician practices. The…
    STAT · 14d agoDealPositive↗ source
  • Employers sue UnitedHealth, alleging overpayment of workers' medical claims
    Six major U.S. companies have filed a lawsuit against UnitedHealth Group, claiming the insurer overpaid medical claims for their employees, which they say increased their costs. The plaintiffs inc…
    Endpoints · 14d agoNegative↗ source
  • WuXi AppTec lifts 2026 revenue outlook despite US defense designation dispute
    WuXi AppTec, a leading Chinese contract research and manufacturing organization, announced it has again lifted its revenue forecast for 2026. The company said the upward revision reflects accelera…
    Endpoints · 14d agoNeutral↗ source
  • House lawmaker probes PBMs over alleged punitive audits of independent pharmacies
    House Committee Chairman James Comer sent letters to CVS Caremark, OptumRx and Express Scripts alleging that independent pharmacies faced a sudden increase in audits after publicly supporting his P…
    STAT · 14d agoRegulatoryNegative↗ source
  • Health insurance premiums surge as CMS ramps up Medicaid fraud crackdown
    Premiums for health insurance are climbing sharply, putting pressure on both large and small employers. While many firms have absorbed the cost to stay competitive, smaller businesses are beginning…
    STAT · 14d agoRegulatoryNegative↗ source
  • SystImmune/BMS and Hengrui showcase ADC data for EGFR-mutant lung cancer at ESMO
    At the European Society for Medical Oncology (ESMO) meeting in Madrid, Li Zhang of Sun Yat-sen University Cancer Center presented early data from the HERON‑Lung01 study, highlighting an antibody‑dr…
    Endpoints · 14d agoNeutral↗ source
  • Experts unveil four-stage framework for women's heart health across the lifespan
    Experts from the American Heart Association, American Academy of Pediatrics, Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists released a new framework…
    STAT · 14d agoPositive↗ source
  • FDA Commissioner Highlights New Rare Disease Framework Emphasizing Patient Voice
    Acting US Food and Drug Administration (FDA) Commissioner Kyle Diamantas highlighted the agency's new rare disease framework during a fireside chat at the NORD Breakthrough Summit. The framework i…
    raps · 15d agoRegulatoryPositive↗ source
  • FDA clears Edwards' tricuspid valve repair device; Bayer's blood thinner asundexian approved in China
    The U.S. Food and Drug Administration has granted approval for Edwards Lifesciences' new tricuspid valve repair system, expanding treatment options for patients with tricuspid regurgitation. In Ch…
    raps · 15d agoApprovalNeutral↗ source