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  • Former FDA chiefs slam Trump administration, label DOGE a disaster and warn of staff loss, while AstraZeneca announces AI partnership
    Three former FDA commissioners publicly rebuked the Trump administration, saying its actions have harmed the agency. They said the administration’s handling of a large staff departure stripped the…
    STAT · 5d agoRegulatoryNegative↗ source
  • Biotech investors grow uneasy as XBI stalls despite overall gains
    Adam Feuerstein notes that while biotech stocks have performed well overall this year, investor sentiment has turned sour after the summer. The SPDR S&P Biotech ETF (XBI) remains up about 24% year…
    STAT · 5d agoNegative↗ source
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  • Experts call for dedicated regulatory framework for clinical AI models, UK MHRA unveils AI-focused strategy
    Former FDA commissioner Scott Gottlieb, now at the American Enterprise Institute, wrote an opinion piece urging Congress to create a specific regulatory framework for artificial intelligence models…
    raps · 5d agoRegulatoryPositive↗ source
  • EMA to cement ACT EU pilot; MHRA unveils AI-era regulatory strategy
    The European Medicines Agency announced that in January 2027 it will make permanent a pilot project that assists sponsors in preparing clinical trial applications, turning a temporary scheme into a…
    raps · 5d agoRegulatoryNeutral↗ source
  • DOJ ramps up health-care fraud investigations, urges companies to self-report and reward remediation
    At the STAT Summit in Boston, DOJ officials announced a renewed focus on health-care fraud, especially targeting Medicare and Medicaid schemes. Deputy Assistant Attorney General Jacob Foster said…
    STAT · 4d agoRegulatoryNegative↗ source
  • Massachusetts Rep. Jake Auchincloss urges Congress to back U.S. biotech instead of targeting China
    At the STAT Summit in Boston, Rep. Jake Auchincloss (D-Mass.) told fellow lawmakers to back the U.S. biotechnology sector without hesitation. He urged Congress to champion biotech, criticize insur…
    STAT · 5d agoPositive↗ source
  • Melanoma patient shares hope after receiving Merck-Moderna mRNA cancer vaccine in trial
    A schoolteacher diagnosed with melanoma in 2019 participated in a late‑stage trial testing an mRNA cancer vaccine developed by Merck and Moderna. The trial added the vaccine to standard immunothera…
    STAT · 5d agoPositive↗ source
  • FDA unveils new rare disease framework to streamline evidence standards and speed therapies
    The FDA announced a new Rare Disease Framework Initiative aimed at standardizing how scientific evidence is evaluated for rare disease therapies. The framework seeks to apply consistent clinical t…
    BioSpace · 5d agoRegulatoryPositive↗ source
  • Vanda halts Novartis-originated social anxiety drug after Phase 3 miss
    Vanda Pharmaceuticals announced it is suspending development of VQW-765, a social anxiety disorder candidate licensed from Novartis, after the drug failed to demonstrate a statistically significant…
    BioSpace · 5d agoNegative readoutNegative↗ source
  • Kenya confirms second Ebola case as Congo outbreak continues
    Kenya health officials have confirmed a second case of Ebola in the country, raising concerns about potential spread. The report comes as the neighboring Democratic Republic of Congo continues to…
    STAT · 5d agoNegative↗ source
  • FDA issues early alert on Edwards Lifesciences transcatheter mitral valve delivery system after balloon burst reports
    The FDA's Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with certain Edwards Lifesciences delivery systems used in the SAPIEN M3 transcatheter m…
    fda medwatch · 5d agoRegulatoryNegative↗ source
  • Compass Pathways CEO says company will proceed cautiously as it readies psychedelic therapy for FDA review
    Compass Pathways chief executive Kabir Nath told reporters at the STAT Summit that the company will "go slow before we go fast," emphasizing that early negative experiences could hurt the emerging…
    STAT · 5d agoRegulatoryNeutral↗ source
  • FDA issues warning letters to manufacturers over CGMP and GLP violations
    The U.S. Food and Drug Administration has sent warning letters to multiple drug manufacturers for failing to meet current good manufacturing practice requirements. The agency highlighted problems e…
    raps · 5d agoRegulatoryNegative↗ source
  • Former FDA commissioners slam current HHS leadership over research cuts and regulatory challenges
    Former FDA commissioners Rob Califf, Scott Gottlieb and Ned Sharpless publicly criticized the officials running the agency, saying the current HHS leadership is failing the FDA. They highlighted m…
    STAT · 5d agoRegulatoryNegative↗ source
  • Verastem reports encouraging early data for KRAS G12D inhibitor in pancreatic cancer
    Verastem Oncology disclosed early clinical results for its KRAS G12D inhibitor, which is being evaluated in more than 200 patients with advanced solid tumors, including metastatic pancreatic ductal…
    STAT · 5d agoPositive readoutPositive↗ source
  • Advocates race to shape rules for AI sandboxes in health care
    The STAT Health Tech newsletter notes that AI sandboxes are becoming a popular mechanism for testing health‑care artificial intelligence under controlled conditions. A broad coalition of industry…
    STAT · 5d agoRegulatoryNeutral↗ source
  • Experts call for Congress to create a dedicated regulatory framework for AI models used in academic medical centers
    On Oct. 15, 2026, several health policy experts voiced support for a new regulatory approach specifically aimed at clinical artificial‑intelligence models that are developed and deployed in academi…
    raps · 5d agoRegulatoryNeutral↗ source
  • Webinar Explores How US Biotechs Can Compete and Collaborate with China’s Growing Industry
    BioSpace is hosting a webinar titled "The China question: Can US biotechs lead as investment heads east?" on October 15, 2026. The event will feature a panel of experts who will discuss how China i…
    BioSpace · 5d agoNeutral↗ source
  • U.S. Health Officials Push Policy to Let Specialty Pharmacies Make Certain Peptide Injections
    The Department of Health and Human Services has submitted an interim access policy for peptides to the White House, where it will be reviewed by the Office of Management and Budget. The proposal w…
    STAT · 4d agoRegulatoryNeutral↗ source
  • Cytiva podcast highlights decision confidence as key bottleneck in biopharma development
    In a recent episode of the Denatured podcast, hosted by BioSpace Insights director Jennifer Smith-Parker, the conversation focused on the challenges facing biopharma companies. The guest, Nicolas P…
    BioSpace · 5d agoNeutral↗ source
  • Personal tragedy highlights deeper flaws in nursing workforce and training gaps
    Lynne S. Moronski, a nurse researcher at the University of Pennsylvania, recounts the loss of her 21‑year‑old daughter, who died after a medication error by direct support professionals in a New Je…
    STAT · 5d agoNegative↗ source
  • Patients struggle to opt out of MyChart data sharing, facing notary and endless hurdles
    An opinion piece highlights how MyChart users who want to stop sharing their health information encounter a maze of requirements. The author describes needing a notary, multiple phone calls, unansw…
    STAT · 5d agoNegative↗ source
  • Around 40% of U.S. high schoolers report binge‑eating in past month, new CDC data shows
    A recent CDC Youth Risk Behavior Survey found that roughly four in ten high school students said they had engaged in binge‑eating during the previous month, marking the first time the biennial surv…
    STAT · 5d agoNegative↗ source
  • FDA launches rare disease framework initiative
    A new initiative from the US Food and Drug Administration (FDA) aims to develop “an optimized, fit-for-purpose” framework to facilitate the development and marketing of treatments for rare diseases…
    raps · 5d ago↗ source
  • FDA expands Anktiva use for BCG-unresponsive high-grade papillary bladder cancer
    The U.S. Food and Drug Administration has broadened the approved use of Anktiva, a therapy given with Bacillus Calmette-Guérin, to treat adults with high-grade papillary-only bladder cancer that ha…
    fda press · 6d agoApprovalPositive↗ source