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145 stories matching this filter · ← front page

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  • Convenience Kit Recall: Medline Issues Correction for Convenience Kits Containing B. Braun Bupivacaine Hydrochloride Components
    Medline is correcting affected convenience kits by removing included B. Braun components containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP.
    fda medwatch · 17h ago↗ 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 · 1d agoLayoffsNegative↗ source
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Infectious Disease356
Study shows antibiotic overuse is concentrated in high-income nations, while low-income countries struggle with shortages
Peter Beyer, deputy executive director of the Global Antibiotic Research & Development Partnership, writes an opinion piece highlighting a shift in how antimicrobial resistance is framed across the…
STAT · 2d agoNeutral↗ source
  • Former NIAID adviser David Morens pleads guilty to concealing records and defrauding government
    David Morens, a former top National Institute of Allergy and Infectious Diseases official and longtime senior adviser to former NIAID leader Anthony Fauci, entered a guilty plea on Tuesday on charg…
    STAT · 1d agoRegulatoryNegative↗ source
  • How AI-enabled Software as Medical Devices are Reshaping Regulatory Routes and Medicine
    As AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, s…
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • Vaccines protect lives: A physician’s reminder of what we lose without them
    Dr. Krutika Kuppalli, an infectious-disease physician and former WHO medical officer, reflects on her frontline work where vaccines were scarce. In Haiti she witnessed a patient die from tetanus,…
    STAT · 7d agoPositive↗ source
  • WHO calls Trump’s vaccine policy order misguided, warns it could increase needle shots and disease risk for children
    WHO Director-General Tedros Adhanom Ghebreyesus and other senior officials criticized a new U.S. executive order that seeks to overhaul the childhood vaccination schedule. The order, signed by Pre…
    STAT · 8d agoRegulatoryNegative↗ source
  • Medline issues correction for convenience kits containing recalled ICU Medical pain management components
    Medline announced a correction for certain convenience kits that include ICU Medical pain management components containing Huons Bupivacaine Hydrochloride in Dextrose Injection. The FDA classified…
    fda medwatch · 8d agoCRLNegative↗ source
  • FDA issues early alert on non-sterile BD ChloraPrep applicators in Medline convenience kits
    The FDA's Center for Devices and Radiological Health (CDRH) released an early alert about a potential high‑risk issue with certain Medline convenience kits that contain BD ChloraPrep applicators th…
    fda medwatch · 8d agoRegulatoryNeutral↗ source
  • Experts warn splitting MMR vaccine into separate shots could increase missed doses and illness
    The article notes that a recent executive order proposes separating the combined measles, mumps and rubella vaccine into three individual injections. The author argues that this change could lead t…
    STAT · 9d agoRegulatoryNegative↗ source
  • French study finds stopping statins in low-risk adults over 75 does not raise mortality
    A new French non-inferiority study published in Lancet Healthy Longevity examined whether discontinuing statin therapy in people older than 75 who have no prior cardiovascular disease would affect…
    STAT · 8d agoPositive readoutNeutral↗ source
  • Trump administration issues executive order questioning childhood vaccine schedule
    The White House unveiled a new executive order that challenges the established childhood vaccine schedule. President Trump announced the measure from the Oval Office, marking a shift after months o…
    STAT · 10d agoRegulatoryNegative↗ source
  • Global Ebola preparedness fixated on one strain, leaving other species vulnerable
    In an opinion piece, infectious-diseases physician Krutika Kuppalli and virologist Placide Mbala argue that the term "Ebola" masks several distinct virus species, each with different diagnostic and…
    STAT · 10d agoNegative↗ source
  • Global Ebola preparedness fixated on one strain, leaving gaps for other species
    Krutika Kuppalli, a former WHO medical officer, and virologist Placide Mbala write that the world’s readiness for Ebola has been narrowly focused. They draw on Kuppalli’s experience in the 2014‑201…
    STAT · 10d agoNegative↗ source
  • Third gender-affirming clinic settles with DOJ as Senate moves to hold Fauci in contempt
    A third clinic that provides gender-affirming services reached a settlement with the Department of Justice, ending a federal investigation into alleged civil-rights violations. The agreement inclu…
    STAT · 13d agoRegulatoryNeutral↗ source
  • Senate hearings blame China, not Fauci, for Covid-19 origin delays
    A Senate committee recently held a hearing on the origins of Covid-19 and concluded that Dr. Anthony Fauci was in contempt of Congress after invoking his Fifth Amendment rights. The author, a prof…
    STAT · 13d agoNegative↗ source
  • Moderna's mRNA flu vaccine mFLUVISA receives FDA approval after earlier filing refusal
    The U.S. Food and Drug Administration initially issued a refusal-to-file letter to Moderna's flu vaccine in February, but a few days later reversed that decision and accepted a revised submission f…
    BioSpace · 14d agoApprovalPositive↗ source
  • FDA approves Moderna's first mRNA flu vaccine for seniors
    The U.S. Food and Drug Administration has granted approval to Moderna’s influenza vaccine for older adults, marking the first licensed flu shot that uses messenger RNA technology. The product, to…
    STAT · 14d agoApprovalPositive↗ source
  • CDC appoints Erica Schwartz as director and Moderna secures approval for mRNA flu vaccine
    The U.S. Centers for Disease Control and Prevention announced that Erica Schwartz has been confirmed as its director, filling a vacancy that has lasted nearly a year. In a separate regulatory upda…
    STAT · 14d agoRegulatoryNeutral↗ source
  • Experts call for independent 9/11‑style commission to review U.S. Covid response
    In an opinion piece, IDSA President Ronald Nahass argues that the United States should create a nonpartisan, 9/11 Commission‑style body to examine the Covid‑19 response. He says such an inquiry wou…
    STAT · 14d agoNeutral↗ source
  • U.S. experts to evaluate if measles elimination status still holds amid rising cases
    Noel T. Brewer, chair of the U.S. National Verification Committee, explains that his group will review the CDC’s annual measles report to decide if the United States continues to meet elimination c…
    STAT · 14d agoNegative↗ source
  • Only one third of US prostate cancer patients received pre-biopsy MRI in 2022, far below Western norms
    MRI is considered the standard pre-biopsy imaging tool for prostate cancer in most western nations, yet a new analysis shows that only about a third of US cases used it in 2022. In the United Stat…
    STAT · 15d agoNegative↗ source
  • Medicaid policy shift could alter primary therapy for children with autism
    The article notes that the main therapy used for children with autism may be affected by upcoming Medicaid policy changes. It highlights that the therapy, which is a cornerstone of treatment for ma…
    STAT · 15d agoRegulatoryNeutral↗ source
  • Ebola outbreak in eastern Congo kills over 1,700 as cases surge past 3,800
    The latest government report shows that the Ebola outbreak in eastern Congo has resulted in more than 1,700 deaths and a total of 3,802 recorded cases. Health officials say that about 60-70% of ne…
    STAT · 16d agoNegative↗ source
  • Two Michigan Cyclospora Deaths Reported as Eli Lilly Expands Special Retatrutide Access
    Two people in Michigan have died after contracting cyclospora, a parasitic infection that is rarely fatal but can be severe for those with underlying health conditions. State health officials confi…
    STAT · 16d agoRegulatoryNeutral↗ source