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  • 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 · 4d agoPositive↗ source
  • IQVIA urges early clinical insight in drug discovery to boost patient benefit
    IQVIA Laboratories' leaders argue that drug discovery and clinical development should be linked early to improve patient outcomes. They explain that decisions made during discovery affect later cl…
    Fierce Biotech · 5d agoPositive↗ source
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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
  • OrbiMed raises $3 billion, its biggest Asian fund yet, to boost biotech investments worldwide
    OrbiMed announced it has closed a $3 billion fundraising round, the largest ever for its Asia‑focused vehicle. The capital will be used to make new growth‑equity and venture investments in biotech…
    Fierce Biotech · 5d agoDealPositive↗ source
  • SimBioSys receives FDA clearance for Nvidia-powered AI tool to predict breast cancer recurrence
    SimBioSys announced FDA clearance for its TumorSight Risk platform, an AI-driven tool that uses MRI, pathology and clinical data to assess the likelihood of breast cancer returning. The cloud-base…
    Fierce Biotech · 5d agoRegulatoryPositive↗ 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
  • Osivax’s flu vaccine OVX836 misses primary efficacy goal in phase 2b trial
    Osivax announced that its influenza A vaccine candidate OVX836 failed to meet the primary efficacy endpoint in a phase 2b trial involving 2,850 healthy adults in Europe. The trial showed a vaccine…
    Fierce Biotech · 5d agoNegative readoutNegative↗ 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
  • Bausch + Lomb CEO Brent Saunders exits again, interim CEO Thomas Appio appointed
    Bausch + Lomb announced that CEO Brent Saunders is leaving the eye health company for a second time, less than four years into his latest tenure. The departure was mutually agreed upon by Saunders…
    Fierce Biotech · 5d agoNeutral↗ 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
  • Lakefront Biotherapeutics sells its cell therapy pipeline to Belgian biotech Armed Cell Therapeutics
    Lakefront Biotherapeutics, formerly known as Galapagos Therapeutics, announced that it has sold its cell therapy pipeline to fellow Belgian biotech Armed Cell Therapeutics. The transferred assets…
    Fierce Biotech · 5d agoDealNeutral↗ 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