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2,157 stories matching this filter · ← front page

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  • 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 · 3mo agoApprovalPositive↗ source
  • Medicare delay adds seven years before AbbVie drug price talks, advocacy group says
    A consumer advocacy group says a policy change by the Trump administration delayed Medicare’s selection of an AbbVie drug for price negotiations by seven years. The delay occurred as the Centers f…
    STAT · 3mo agoRegulatoryNegative↗ source
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  • FDA approves Moderna's mRNA flu vaccine for older adults, first of its kind
    The U.S. Food and Drug Administration has granted approval for Moderna's influenza vaccine designed for older adults. This marks the first licensed flu shot that uses messenger RNA technology. The…
    STAT · 3mo 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 · 3mo agoRegulatoryNeutral↗ source
  • Tenax Therapeutics to Release Phase 3 Heart Failure Trial Results Soon
    Tenax Therapeutics announced that it will soon disclose data from its Phase 3 trial of a heart-failure treatment. The study is being watched as one of the largest binary events left for biotech st…
    STAT · 3mo agoNeutral↗ source
  • AI’s role in medicine isn’t monolithic, says industry leader, urging nuanced adoption
    Priya Abani, CEO of health‑tech firm AliveCor, argues that asking whether AI is good for medicine is a question with an obvious answer: it is. She says the debate has become redundant and that the…
    STAT · 3mo agoPositive↗ source
  • Medline recalls Hudson RCI neonatal heated wire breathing circuits over connector overheating risk
    Medline Industries announced a nationwide recall of its Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits. The recall was triggered after the company received reports of sporadic failures i…
    fda medwatch · 3mo agoRegulatoryNegative↗ 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 · 3mo agoNeutral↗ source
  • Medicare advances ACCESS pilot but leaves patients unaware of participating providers
    STAT's Health Tech newsletter reports that Medicare is promoting its ACCESS chronic‑care pilot, yet patients cannot see which providers are offering the program. A one‑month progress check highlig…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • US moves to shut Kentucky organ donation nonprofit over safety failures
    The U.S. Health Secretary announced that the federal government will begin the process to decertify Network for Hope, a Kentucky-based organ procurement organization, after allegations of safety la…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Senate committee votes to hold Dr. Fauci in contempt over Covid testimony
    A Senate committee voted along party lines to hold former health official Dr. Anthony Fauci in contempt of Congress after he refused to answer questions about his role in the Covid 19 pandemic resp…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Biotech leader Greg Verdine enjoys a successful year with multiple wins
    Greg Verdine, a scientist who moved into biotech leadership, is reported to be having a very good year. According to the source, Verdine has notched several wins in his role, though the specifics…
    STAT · 3mo agoPositive↗ 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 · 3mo agoNegative↗ source
  • Second child death reported in Chinese CRISPR trial for Duchenne muscular dystrophy raises safety concerns
    A second child death has been reported from a Chinese CRISPR gene-editing trial aimed at treating Duchenne muscular dystrophy, reviving concerns about the safety and transparency of such studies.…
    STAT · 3mo agoRegulatoryNegative↗ source
  • FDA approves Takeda’s orexin receptor agonist for narcolepsy, opening new drug class
    The FDA has granted approval to Takeda's novel narcolepsy medication, the first orexin receptor agonist to receive clearance. The twice‑daily pill, marketed as Orzeyful, is indicated for narcoleps…
    STAT · 3mo agoApprovalPositive↗ source
  • Victory Medical Center Pharmacy recalls glutathione vials over high endotoxin levels
    Victory Medical Center Pharmacy in Austin announced a voluntary recall of specific lots of its compounded glutathione 200 mg/mL multi‑dose vials. Testing at the pharmacy detected elevated bacteria…
    fda medwatch · 3mo agoCRLNegative↗ source
  • Erica Schwartz confirmed as CDC director, ending year-long vacancy
    Erica Schwartz was confirmed on Wednesday as the director of the Centers for Disease Control and Prevention, ending a vacancy that lasted almost a year. The Senate approved her appointment by a 51-…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Medicare GUARD pilot faces biotech push to spare rare disease drugs as Moderna begins first-in-human Ebola vaccine trial
    The Medicare Part D GUARD pilot, designed to lower retail drug prices, is under scrutiny because excluding rare disease medicines would erase most of the projected savings, according to STAT. Biot…
    STAT · 3mo agoRegulatoryNeutral↗ 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 · 3mo agoNegative↗ source
  • Excluding orphan drugs from Medicare pricing pilots could erase most savings, analysis shows
    A Harvard researcher has calculated that removing rare disease treatments from two Medicare pilot programs-GLOBE and GUARD-would dramatically cut the projected cost savings. The pilots are designe…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Fresenius Kabi recalls one lot of Morphine Sulfate Injection after labeling error mixes Dilaudid syringes
    Fresenius Kabi announced a voluntary recall of a single lot of its Morphine Sulfate Injection USP, Simplist 2 mg/1 mL product. The recall stems from a labeling mistake where the MicroVault contain…
    fda medwatch · 3mo agoCRLNegative↗ source
  • Federal regulators hold closed-door meetings with tech firms to advance clinical AI adoption
    Federal health officials, including the FDA, CMS and HHS, convened a closed-door "clinical AI demo day" to discuss how to safely expand the use of artificial intelligence in clinical settings. The…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Early-stage trial shows fecal microbiome capsules improve peanut tolerance in some participants
    An early-phase clinical study examined whether oral capsules containing fecal microbiome material could help people with peanut allergy. Six volunteers received the treatment and were later exposed…
    STAT · 3mo agoPositive readoutPositive↗ source
  • Moderna begins early-stage trial of mRNA Ebola vaccine
    Moderna announced the launch of an early-phase clinical trial testing an mRNA vaccine designed to protect against Ebola virus. The study will enroll healthy volunteers to evaluate the vaccine's saf…
    STAT · 3mo agoNeutral↗ 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 · 3mo agoRegulatoryNeutral↗ source