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3,301 stories matching this filter · ← front page

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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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  • Oxford biotech OMass Therapeutics secures $310 million to advance genetic adrenal disorder program
    Oxford-based OMass Therapeutics announced a $310 million private financing round, one of the largest recent fundraises for a UK biotech. The capital will fund the development of therapies targetin…
    Endpoints · 5d agoDealNeutral↗ source
  • 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 · 5d 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
  • OrbiMed secures $3 billion for new life science funds, with over $1 billion earmarked for Asia
    OrbiMed, a leading global investor in life science companies, announced the closing of two new funds that together total about $3 billion. The capital will be deployed across a range of private equ…
    Endpoints · 5d agoDealPositive↗ 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
  • Vanda pauses social anxiety program after Phase 3 trial misses endpoint in women
    Vanda Pharmaceuticals announced Wednesday that it is halting development of its social anxiety disorder candidate after a late-stage trial did not achieve its primary goal. The experimental drug,…
    Endpoints · 5d agoNegative readoutNegative↗ source
  • Nvidia-backed Iambic Therapeutics raises $150M in IPO, begins trading Thursday
    Iambic Therapeutics, a biotech focused on using artificial intelligence to develop cancer treatments, announced the completion of its initial public offering. The company sold 9.38 million shares…
    Endpoints · 5d agoDealPositive↗ 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
  • Former Galapagos CEO Paul Stoffels aims to revive cell therapy projects at new biotech Armed Cell
    Paul Stoffels, who recently stepped down as chief executive of Belgian drug developer Galapagos, is turning his attention to cell‑based therapies. After leaving Galapagos last year, Stoffels has j…
    Endpoints · 5d agoDealPositive↗ 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
  • Family Farmstead Dairy Announces Recall of Raw Mild Cheddar Cheese Due to Potential E. coli O157:H7 Contamination
    WORCESTER, NY, October 15, 2026 - Family Farmstead Dairy of Worcester, NY is recalling specific lot of cheddar cheese because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli…
    fda recalls · 5d agoRegulatoryNeutral↗ source
  • Osivax shifts to combination strategy after Phase 2b flu vaccine setback
    Osivax, a French biotech, reported that its lead influenza vaccine candidate did not meet primary endpoints in a Phase 2b study. The trial, which evaluated the vaccine as a standalone product, sho…
    Endpoints · 5d agoNegative readoutNegative↗ source
  • AI tools push physicians to prioritize clinical reasoning over memorization, experts say
    During a recent Endpoints News panel, health‑tech experts highlighted how artificial‑intelligence applications are reshaping the competencies doctors need. They argued that AI can handle routine d…
    Endpoints · 5d agoPositive↗ 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 · 5d agoRegulatoryNeutral↗ source
  • NorthStar Medical Technologies partners with Chinese CRO Quarkmed, while Lonza outlines mid-term guidance
    NorthStar Medical Technologies, a maker of radioisotopes, announced a new partnership with Beijing-based contract research organization Quarkmed. Under the agreement, Quarkmed will provide contrac…
    Endpoints · 5d agoDealNeutral↗ 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