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2,093 stories matching this filter · ← front page

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  • FDA issues draft guidance for electronic IDE submissions via eSTAR
    The U.S. Food and Drug Administration released draft guidance outlining how sponsors can submit investigational device exemption (IDE) applications using the electronic Submission Template and Reso…
    raps · 12d agoRegulatoryNeutral↗ source
  • U.S. overdose deaths fell 27% in 2024, with early 2025 data showing further decline
    U.S. overdose mortality dropped 27% in 2024 after years of steep increases, and preliminary figures for 2025 suggest the trend is continuing, though the overall death rate remains high. A Health a…
    STAT · 12d agoPositive↗ source
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  • Pediatricians work to calm families and promote MMR vaccination amid Pennsylvania measles outbreak
    A pediatrician at the Children’s Hospital of Philadelphia describes a growing measles outbreak in Pennsylvania, noting more than 1,300 reported cases with roughly a third affecting children. Paren…
    STAT · 12d agoNeutral↗ source
  • Michigan Senate candidate Abdul El-Sayed vows to challenge RFK Jr. and push Medicare for All
    Abdul El‑Sayed, a Michigan Democrat and former public‑health official, is nearing the end of a contentious Senate campaign. He has announced he will aggressively question Robert F. Kennedy Jr., lab…
    STAT · 12d agoNeutral↗ source
  • Physician's personal egg-freezing story highlights systemic sexism in fertility industry
    In an opinion piece, NYU assistant professor Pooja Yerramilli reflects on her own egg-freezing experience after Democratic Representative Alexandria Ocasio-Cortez sparked a national conversation ab…
    STAT · 12d agoNegative↗ source
  • STAT seeks input on how Epic's practices affect hospital technology choices
    Epic is the largest electronic health records vendor in the United States, with its systems used by most large health systems and covering the health data of roughly eight in ten Americans. Indust…
    STAT · 12d agoNeutral↗ source
  • STAT+: Lilly’s triple-G drug beats Ozempic in head-to-head study
    Eli Lilly announced that its investigational drug retatrutide was more effective at lowering blood sugar and cutting weight than Novo Nordisk’s Ozempic in a large diabetes study.
    STAT · 12d ago↗ source
  • Phase 3 trial shows cancer vaccine intismeran autogene cuts recurrence risk by 42% versus Keytruda
    At the European Society for Medical Oncology Congress, a Phase 3 trial of the personalized cancer vaccine intismeran autogene reported a 42% reduction in risk of recurrence or death compared with p…
    STAT · 13d agoPositive readoutPositive↗ 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 · 13d 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 · 13d agoRegulatoryPositive↗ 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 · 13d 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 · 13d agoPositive↗ 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 · 13d 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 · 13d 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 · 13d 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 · 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 · 13d agoCRLNegative↗ 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 · 13d 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 · 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 · 13d 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 · 13d 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