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  • FDA approves first mRNA seasonal flu vaccine, mFlusiva, a year after funding cuts
    The U.S. Food and Drug Administration granted approval to mFlusiva, the first mRNA‑based seasonal influenza vaccine, after its advisory committee voted unanimously that the benefits outweigh the ri…
    STAT · 1mo agoApprovalPositive↗ source
  • FDA approves Moderna's first mRNA flu vaccine for adults 50 and older
    The Food and Drug Administration has granted approval to Moderna's mRNA flu vaccine, called mFlusiva and previously known as mRNA-1010, making it the first preventive flu shot built on messenger RN…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
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Infectious Disease459
  • Study uncovers tau’s role in reversing mitochondrial electron flow, offering new Alzheimer’s drug target
    A Stanford-led research team has identified a previously unknown way that the protein tau disrupts cellular function, adding to its status as a leading target in Alzheimer’s drug development. The…
    STAT · 1mo agoPositive readoutPositive↗ source
  • FDA approves Takeda’s narcolepsy drug and the first mRNA flu vaccine
    The U.S. Food and Drug Administration has granted approval to a new narcolepsy treatment developed by Takeda, marking a significant addition to the therapeutic options for the sleep disorder. In a…
    STAT · 1mo 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 · 1mo agoApprovalPositive↗ source
  • Replimune's oncolytic virus therapy Tudriqev receives FDA accelerated approval for advanced melanoma
    The U.S. Food and Drug Administration has granted approval to Replimune's melanoma treatment, ending a series of earlier rejections after an advisory panel advocated for the drug. The therapy, pre…
    BioPharma Dive · 1mo 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 · 1mo agoRegulatoryNegative↗ source
  • Tarsus to acquire eye-drug startup Alkeus in up to $800 million deal
    Tarsus Pharmaceuticals announced Thursday that it will buy Alkeus Pharmaceuticals for up to $800 million, consisting of $270 million in cash and $180 million in stock. The agreement also provides…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Erica Schwartz confirmed as CDC director after year-long leadership void
    Senate confirmed Erica Schwartz, a public-health veteran and vaccine supporter, as the new head of the CDC. She takes over an agency that has operated without a permanent director for almost a yea…
    BioPharma Dive · 1mo agoNeutral↗ source
  • LifeMine secures $263M to advance fungal-derived organ transplant drug
    LifeMine Therapeutics announced it has closed two venture financings that together raised $263 million. The capital will be used to push its experimental therapy, LIFE-001, further along the develo…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoPositive↗ source
  • Cardiac biotech Braveheart raises $382.5M in IPO, launches on Nasdaq as BRVE
    Braveheart Bio, a cardiac drug developer, priced its initial public offering on Wednesday and secured $382.5 million in proceeds. The company sold about 21.2 million shares at $18 each, exceeding t…
    BioPharma Dive · 1mo agoDealPositive↗ 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoRegulatoryNegative↗ source
  • Lilly beats forecasts while Novo Nordisk misses sales and trial targets
    Eli Lilly reported second-quarter revenue of nearly $23 billion, up 48% year-over-year, easily surpassing analysts’ $20.6 billion estimate. The boost came from continued strength of its tirzepatide…
    BioPharma Dive · 1mo agoEarningsNeutral↗ 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 · 1mo agoApprovalPositive↗ source