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  • FDA launches Rare Disease Framework Initiative to overhaul review process
    The FDA announced a new Rare Disease Framework Initiative aimed at redesigning how therapies for rare conditions are regulated. The initiative will move away from a one-size-fits-all model, instea…
    BioPharma Dive · 27d agoRegulatoryPositive↗ source
  • 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 · 27d agoRegulatoryNegative↗ source
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  • 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 · 27d agoNegative↗ source
  • Iambic Therapeutics raises $150 million in IPO, begins Nasdaq trading under ticker IAM
    Iambic Therapeutics, an AI-driven drug discovery startup, completed an initial public offering that raised $150 million. The company sold about 9.4 million shares at $16 each and will start tradin…
    BioPharma Dive · 28d agoDealPositive↗ 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 · 27d 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 · 27d agoPositive↗ source
  • Belgian startup Armed Cell Therapeutics acquires Galapagos-derived CAR-T assets for €8 million upfront
    Armed Cell Therapeutics, a new Belgian biotech chaired by former Galapagos CEO Paul Stoffels, has taken ownership of several cell therapy programs previously held by Lakefront Biotherapeutics. The…
    BioPharma Dive · 27d agoDealPositive↗ 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 · 27d agoPositive↗ 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 · 27d 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 · 27d 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 · 28d agoRegulatoryNeutral↗ 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 · 27d 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 · 27d 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 · 27d agoRegulatoryNeutral↗ 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 · 27d agoRegulatoryNeutral↗ 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 · 27d 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 · 27d 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 · 27d agoNegative↗ 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 · 28d agoApprovalPositive↗ source
  • CVS agrees to $315 million settlement over alleged improper opioid prescriptions
    CVS Pharmacy has agreed to pay $315 million to settle federal allegations that it dispensed unnecessary opioid prescriptions. The Justice Department claims the company filled prescriptions that we…
    BioPharma Dive · 28d agoRegulatoryNegative↗ source
  • Arrowhead’s experimental RNAi drug ARO-MAPT cuts tau protein by 73% in early human trial
    Arrowhead Pharmaceuticals said its experimental RNA interference therapy, ARO-MAPT, lowered the Alzheimer’s‑linked tau protein in a first‑in‑human study of healthy volunteers. The early‑stage tria…
    BioPharma Dive · 28d agoPositive readoutPositive↗ source
  • Johnson & Johnson shares drop 6% after earnings meet forecasts but show weak medical device outlook
    Johnson & Johnson reported third‑quarter results that met Wall Street expectations and raised its 2026 financial guidance, yet the stock fell about 6% on the day. Analysts highlighted an underwhel…
    BioPharma Dive · 28d agoEarningsNegative↗ source
  • Whoop joins Medicare ACCESS program to offer free wearables and support to seniors
    Whoop, known for fitness wearables aimed at athletes, has been accepted into Medicare’s ACCESS pilot, allowing the company to provide its device and a year‑long subscription to eligible Medicare be…
    STAT · 28d agoPositive↗ source
  • FDA launches Rare Disease Framework Initiative to reshape drug development for small patient populations
    The FDA announced a new Rare Disease Framework Initiative aimed at overhauling how drugs and biologics for rare conditions are developed. The initiative will produce a tailored framework that refl…
    fda press · 28d agoRegulatoryPositive↗ source
  • Verastem’s experimental KRAS drug shows early promise in small study, shares jump 18%
    Verastem Oncology announced early data from a small study of its experimental drug VS-7375, which targets the KRAS G12D mutation. The study enrolled patients with metastatic pancreatic ductal aden…
    BioPharma Dive · 28d agoPositive readoutPositive↗ source