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2,748 stories matching this filter · ← front page

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  • 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 · 1mo 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 · 29d agoPositive↗ source
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  • 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 · 29d 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 · 29d agoPositive readoutPositive↗ 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 · 29d 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 · 1mo agoRegulatoryNegative↗ 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 · 1mo 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 · 1mo 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 · 29d 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 · 29d 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 · 1mo 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 · 1mo 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 · 29d 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 · 1mo 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 · 1mo agoPositive↗ source
  • Early-life gut microbiome may influence lifelong brain health, experts say
    The authors argue that the composition of a baby’s gut microbiome could play a pivotal role in shaping brain development and later cognitive health. They suggest that understanding this link may he…
    STAT · 1mo agoNeutral↗ source
  • BlackRock to acquire majority stake in Humana’s CenterWell clinics for $2.8 billion
    Humana announced that BlackRock will purchase Welsh Carson’s majority stake in the CenterWell Senior Primary Care network, a deal valued at $2.8 billion. The transaction covers roughly 150 Medicare…
    STAT · 1mo agoDealPositive↗ source
  • Study finds nearly 40% of FDA advisory panels include reps linked to pharma-funded advocacy groups
    A new analysis published in Health Affairs Scholar examined FDA advisory committee meetings over the past 20 years and found that almost 40% featured a patient or consumer representative with activ…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Roche signs $1 billion deal with China’s Rona Therapeutics for RNAi obesity drug
    Roche announced a new agreement with Chinese biotech Rona Therapeutics to acquire an experimental RNA interference therapy targeting the protein ALK7 for obesity. Under the terms, Roche will pay $…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Study urges regulators to adopt cloud platforms to speed drug approvals
    A new study led by Nina Cauchon of Amgen and co-authors, published in the Journal of Pharmaceutical Sciences, calls for broader use of cloud-based platforms by regulatory agencies. The authors arg…
    raps · 1mo agoRegulatoryPositive↗ source
  • Connectivity in fluid management systems key to reducing process variability
    The sponsored article, authored by Chris McCoy of Cytiva, highlights the often‑overlooked role of fluid‑management components such as tubing, connectors, and sensors in bioprocesses. It argues tha…
    BioPharma Dive · 1mo agoPositive↗ source
  • Patient advocates and experts raise alarm over safety of Neurocrine Biosciences rare disease drug
    Two months after an open letter highlighted possible safety issues, patient advocacy groups and several experts are publicly voicing growing alarm about a rare disease therapy marketed by Neurocrin…
    STAT · 1mo agoNegative↗ source
  • Trump administration proposes $70,000 fee to curb foreign student work authorizations
    The Department of Homeland Security announced a proposed $70,000 fee for a work authorization program that many foreign students and scholars use to gain professional experience in the United State…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Safety concerns rise as Neurocrine's Prader-Willi drug linked to deaths and hospitalizations
    Patient advocates and several experts are voicing increasing alarm over the safety profile of Neurocrine Biosciences' therapy for Prader-Willi syndrome. The drug, Vykat XR, received approval 18 mo…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Stakeholders urge FDA to adopt flexible approach for psychedelic drug regulation
    Various individuals and groups have submitted comments urging the U.S. Food and Drug Administration to be flexible in regulating psychedelic medicines that could treat major depressive disorder and…
    raps · 1mo agoRegulatoryNeutral↗ source