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3,249 stories matching this filter · ← front page

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  • Rock Health summit in San Francisco offers a mid-year health AI landscape check
    The author traveled to San Francisco to attend Rock Health's annual summit, noting it was the first visit in six months. The event gathered health-technology leaders and investors, focusing on the…
    Endpoints · 5d agoNeutral↗ 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
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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
  • Sanofi R&D chief urges Western pharma to factor China’s growing innovation into pipelines
    Sanofi’s newly appointed head of research and development said on Wednesday that Western pharmaceutical companies can no longer overlook China’s rapid progress in biopharma innovation. He noted th…
    Endpoints · 5d agoNeutral↗ source
  • FDA proposes new framework prioritizing consistency over flexibility for rare disease drug reviews
    The FDA announced a shift in its approach to evaluating rare disease therapies, emphasizing a more uniform assessment process. Agency officials explained that the flexibility shown over the summer…
    Endpoints · 5d agoRegulatoryNeutral↗ 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 · 5d 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 · 6d agoRegulatoryPositive↗ source
  • Ultragenyx sells second priority review voucher as Biomea shares tumble after oral GLP-1 data
    Ultragenyx Pharmaceutical, a commercial-stage rare disease company, completed its second sale of a priority review voucher this month. The voucher sale reflects the company's strategy of monetizin…
    Endpoints · 6d agoDealNeutral↗ source
  • Study finds almost 40% of FDA advisory committee meetings in past two decades included members with active industry ties
    Researchers examined FDA advisory committee meetings spanning the last 20 years and discovered that nearly 40% of those sessions featured a patient or consumer representative who had active ties to…
    STAT · 6d agoRegulatoryNeutral↗ source
  • FTC and states seek contempt order against Martin Shkreli for breaching pharma work ban
    The U.S. Federal Trade Commission, joined by seven states, asked a federal court to hold former biotech executive Martin Shkreli in contempt. The request cites repeated violations of a court order…
    STAT · 6d agoRegulatoryNegative↗ source
  • Vir Biotechnology signs $65M upfront deal with Gilead for solid tumor T-cell engager
    Vir Biotechnology announced a new collaboration with Gilead Sciences focused on a solid tumor T-cell engager. Under the agreement, Gilead will provide an upfront payment of $65 million and up to $…
    Endpoints · 6d agoDealPositive↗ source
  • Arrowhead’s RNA drug cuts Alzheimer’s tau protein in early human study
    Arrowhead Pharmaceuticals reported early-stage data showing its subcutaneous RNA therapeutic can reach the brain and lower tau protein, a hallmark of Alzheimer’s disease. In a first-in-human trial…
    Endpoints · 6d agoPositive readoutPositive↗ source
  • Zealand Pharma signs up to $1.3 billion AI partnership with Generate Biomedicines for protein-based obesity drugs
    Zealand Pharma announced a partnership with Generate Biomedicines to develop new protein-based treatments targeting obesity and related metabolic conditions. The collaboration will use Generate's…
    Endpoints · 6d agoDealPositive↗ source
  • GSK to cut up to 1,200 jobs in Belgium as part of cost-cutting plan
    GSK said it will make up to 1,217 workers redundant from its facilities in Belgium. The job reductions are part of a cost-cutting programme that CEO Luke Miels first outlined in July. The announc…
    Endpoints · 6d agoLayoffsNegative↗ source
  • States could counter potential Trump administration vaccine shortages by producing vaccines themselves
    Joel Dodge, director of industrial policy at Vanderbilt Policy Accelerator, warns that the Trump administration is considering changes to the Vaccine Injury Compensation Program, a policy that has…
    STAT · 6d agoRegulatoryNegative↗ source
  • UK regulator MHRA unveils multi-year plan to speed AI-driven drug oversight
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released a multi-year strategy aimed at keeping its regulatory framework patient-focused as artificial intelligence and persona…
    raps · 6d agoRegulatoryNeutral↗ source
  • Former FDA leaders denounce agency layoffs as historic disaster
    Three former Food and Drug Administration commissioners publicly condemned the recent staffing reductions at the agency, calling the moves a major failure of policy. Rob Califf, who served as FDA…
    STAT · 5d agoLayoffsNegative↗ source
  • Trump administration delays rule that could curb imported prescription drugs
    The Trump administration announced a 90‑day postponement of a federal rule that would have limited Americans’ ability to purchase prescription medicines from licensed pharmacies abroad. The rule w…
    STAT · 5d agoRegulatoryPositive↗ source
  • Sanofi avoids fine as EU ends antitrust probe over alleged disparagement of rival flu vaccine
    EU antitrust regulators have closed a probe into Sanofi after the company offered concessions, allowing it to avoid a monetary penalty. The investigation centered on a campaign that allegedly port…
    STAT · 6d agoRegulatoryNeutral↗ source
  • Doctors, hospitals and insurers lobby states on medical AI regulation
    A coalition of lobbying groups representing physicians, hospitals, a health insurer and AI firms met in Washington to craft guidance for state regulation of medical AI. The group, organized by the…
    STAT · 6d agoRegulatoryNeutral↗ source
  • MIT reports 20% drop in graduate enrollment after $100 million federal research cut, warning of basic-research drought
    MIT President Sally Kornbluth told the STAT Summit that the university saw a 20% decline in new graduate students this fall, linked to a $100 million reduction in federal research awards over the p…
    STAT · 5d agoRegulatoryNegative↗ source
  • Study explores how GLP-1 weight-loss drugs affect criminal justice involvement, job prospects and housing stability
    A new research effort is looking at how GLP-1 based weight‑loss medications influence outcomes beyond health, specifically interactions with the criminal justice system, employment prospects and ho…
    STAT · 6d agoNeutral↗ source
  • Radical Numerics aims to develop general biological intelligence, says CEO Eric Nguyen
    STAT’s AI Prognosis newsletter features an interview with Eric Nguyen, chief executive of Radical Numerics. The Boston-based startup says it is working toward what it calls “general biological inte…
    STAT · 6d agoPositive↗ source
  • Verastem makes its stand as a RevMed competitor in pancreatic cancer
    Verastem Oncology had a big Wednesday morning: It announced new data amid a tense competition for the next-wave KRAS agents, as well as a $250 million raise and the departure of its CEO. The Massac…
    Endpoints · 6d agoNeutral↗ source