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395 stories matching this filter · ← front page

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  • FDA Grants Accelerated Approval for Jemperli Immunotherapy in Locally Advanced Rectal Cancer
    The U.S. Food and Drug Administration has granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab‑gxly). The approval applies to adults with previously untreated stage…
    fda press · 17h agoApprovalPositive↗ source
  • Merck/Moderna vaccine and Summit/Akeso bispecific therapy among key highlights at ESMO 2026
    The European Society of Medical Oncology (ESMO) meeting in Madrid this weekend will showcase several high‑profile oncology programs. Among the most watched are Merck and Moderna’s personalized can…
    BioSpace · 1d agoNeutral↗ source
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  • Former GOP lawmakers warn that confusing vaccine messaging could hurt party's midterm prospects
    Two former Republican congressmen say the party's mixed messaging on vaccines has become a political liability. They argue that the lack of a clear stance could alienate voters and damage Republic…
    STAT · 20h agoNegative↗ source
  • Measles resurgence threatens Republican midterm prospects, physicians warn
    Physicians and former Republican congressmen Larry Bucshon and Michael C. Burgess wrote an opinion piece warning that the recent measles surge is turning into a political liability for the GOP. Va…
    STAT · 1d agoNegative↗ source
  • Merck and Moderna plan to seek approval for personalized mRNA melanoma vaccine after Phase 3 shows delayed recurrence
    At the 2026 STAT Summit, Merck and Moderna outlined their partnership to combine Keytruda with a personalized mRNA cancer vaccine aimed at melanoma patients. In a large Phase 3 trial, the vaccine…
    STAT · 4d agoRegulatoryPositive↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 4d agoLayoffsNegative↗ 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 · 5d agoApprovalPositive↗ 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 · 5d agoRegulatoryPositive↗ source
  • GSK to cut over 1,200 jobs at Belgian sites as $2.5 bn restructuring continues
    GSK announced it will eliminate more than 1,200 positions across its Belgian facilities, following an earlier closure of a German vaccine plant that cut about 650 jobs. The reductions are part of…
    BioSpace · 5d 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
  • 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
  • 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 · 5d agoRegulatoryNeutral↗ 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 · 5d agoNeutral↗ source
  • BioNTech's head and neck cancer mRNA vaccine fails to extend progression-free survival in Phase 3 trial
    BioNTech reported that its experimental mRNA immunotherapy BNT113 did not meet its primary endpoint in a Phase 3 trial for a specific head and neck cancer, failing to improve progression-free survi…
    BioSpace · 6d agoNegative readoutNegative↗ source
  • Par Health initiates voluntary recall of Argatroban injection after detecting particulate contaminants
    Par Health USA announced a voluntary nationwide recall of its Argatroban Injection 250 mg/2.5 mL product, affecting 22 lots that have been distributed to hospitals and users. The recall was trigge…
    fda recalls · 6d agoRegulatoryNegative↗ 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 · 6d agoRegulatoryNegative↗ source
  • Veteran infectious disease journalist Helen Branswell dies at 69
    Helen Branswell, a veteran reporter covering infectious diseases, died on Tuesday at age 69. Her sister said the cause was complications from cancer. Branswell was known for clear, nuanced coverag…
    STAT · 6d agoNeutral↗ source
  • GSK to invest $800 million in new biologics manufacturing hub in Pennsylvania
    GSK announced it will spend more than $800 million to expand its Upper Merion site near Philadelphia, adding biologics production capacity. The plan includes demolishing existing structures next y…
    BioSpace · 7d agoDealPositive↗ source
  • Americans show higher trust in science than most countries, survey finds
    A new Wellcome Global Monitor survey of people in 140 countries found that 52% of Americans say they have a lot of trust in science, compared with just 26% globally. Only 40% of Americans reported…
    STAT · 9d agoNeutral↗ source
  • Novartis licenses Abogen’s mRNA CD19×CD3 engager in $575M upfront deal
    Abogen Biosciences saw its COVID vaccine miss the market, prompting questions about whether its mRNA platform could be leveraged for other therapies. Novartis agreed to pay $575 million up front f…
    BioSpace · 10d agoDealPositive↗ source
  • Half-century after IL-2 discovery, its impact on HIV, cancer and blood safety is highlighted
    Robert Gallo marks the 50-year anniversary of the 1976 paper that described interleukin-2, one of the first cytokines identified and essential for T-cell growth. He notes that IL-2 enabled the dis…
    STAT · 11d agoPositive↗ source
  • FDA week: HHS launches vaccine injury study, midterms may reshape oversight committees, and patent thickets threaten generics
    The Department of Health and Human Services announced a new agency‑wide effort to examine and address injuries that may be linked to vaccines. The initiative will coordinate research across FDA and…
    raps · 11d agoRegulatoryNeutral↗ source
  • AstraZeneca launches $1 billion R&D hub in Boston’s Kendall Square
    AstraZeneca opened a new research and development site in Kendall Square, Boston, marking a $1 billion investment in the U.S. biotech corridor. The Boston location underscores the company’s commit…
    STAT · 13d agoNeutral↗ source
  • Experts warn FDA against approving Grail’s ineffective multicancer blood test
    Physician and cancer‑screening researcher H. Gilbert Welch argues that the FDA should not greenlight Grail’s multicancer blood test, noting the company’s trial of 140,000 participants used a weak s…
    STAT · 14d agoRegulatoryNegative↗ source
  • Trump proposes $90 monthly aid for seniors as stem cell therapies gain attention
    STAT's D.C. Diagnosis newsletter notes that stem cell treatments are being discussed as a possible next breakthrough in medicine, likening them to the rise of peptide therapies. President Trump an…
    STAT · 13d agoNeutral↗ source