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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 · 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
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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 · 1mo agoApprovalPositive↗ source
  • Tarsus Pharma to spend $450M upfront acquiring Alkeus to expand its ophthalmology pipeline
    Tarsus Pharmaceuticals announced it will acquire Alkeus Pharmaceuticals, a Phase 3 biotech focused on a Stargardt disease drug, for an upfront payment of $450 million. The deal is intended to broad…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA outlines pilot to speed IND submissions for up to 10 drug programs
    The Food and Drug Administration has released details of a new pilot program designed to accelerate the Investigational New Drug (IND) filing process for selected candidates. The agency plans to w…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Teva agrees to $35 million settlement over delayed generic asthma inhalers
    A Massachusetts federal judge approved a settlement involving Teva Pharmaceuticals and several healthcare funds. The agreement sets the payment at $35 million to resolve the dispute. The funds al…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Intellia finds genetic marker linked to liver enzyme spikes in CRISPR ATTR amyloidosis trial
    Intellia Therapeutics announced that analysis of its ongoing CRISPR gene-editing trial for transthyretin (ATTR) amyloidosis has identified a common genetic variant among participants who experience…
    Endpoints · 1mo agoNegative readoutNegative↗ 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
  • Vedanta Biosciences secures $60 million to complete Phase 3 trial of C. difficile microbiome therapy
    Vedanta Biosciences, a Cambridge, MA biotech focused on microbiome therapeutics, announced it has raised $60 million in new financing. The capital will be used to advance its lead candidate target…
    Endpoints · 1mo agoDealPositive↗ source
  • LifeMine Therapeutics secures $263 million to develop safer transplant immunosuppressant
    LifeMine Therapeutics announced it has raised a total of $263 million through two venture financing rounds. The capital, which includes a newly disclosed $75 million Series D round, will be used t…
    Endpoints · 1mo agoDealPositive↗ 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
  • FDA approves Moderna flu vaccine
    The U.S. Food and Drug Administration granted approval to Moderna's seasonal flu vaccine, adding another product to the company's portfolio. The approval was announced late Wednesday, after a repo…
    Endpoints · 1mo agoApprovalPositive↗ source
  • Revolution Medicines readies launch of experimental pancreatic cancer drug daraxonrasib as approval decision pending
    Revolution Medicines executives say they are preparing to launch daraxonrasib, an experimental therapy for metastatic pancreatic cancer. The drug is currently awaiting regulatory decisions in the…
    Endpoints · 1mo agoNeutral↗ source
  • Sarepta delays Elevidys study readout while Emergent cuts 90 jobs
    Sarepta Therapeutics told investors that the readout for its non‑ambulatory Elevidys trial will not be available by the end of the year as previously expected. The company indicated the delay durin…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Braveheart Bio raises $383 million in Nasdaq IPO to advance Hengrui cardiovascular drug to Phase 3
    Braveheart Bio, a U.S. biotech spun out of China’s Hengrui Pharmaceuticals, completed an initial public offering on the Nasdaq. The offering generated about $383 million in gross proceeds, providi…
    Endpoints · 1mo agoDealPositive↗ 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
  • Tiziana Life Sciences CEO Ivor Elrifi buys 321,423 shares, raising his stake to 4.79 million
    Tiziana Life Sciences announced that its chief executive, Ivor Elrifi, purchased 321,423 common shares of the company on NASDAQ at $1.00 per share. The transaction brings Elrifi’s total ownership…
    globenewswire health · 1mo agoDealPositive↗ source
  • Novo Nordisk reports board and executive share transactions under EU market abuse rules
    On August 6, 2026 Novo Nordisk issued a company announcement detailing share transactions made by members of its board, senior executives and their close associates in line with Article 19 of EU Re…
    globenewswire health · 1mo agoRegulatoryNeutral↗ source
  • Tiziana Life Sciences CEO Ivor Elrifi boosts stake, buying 321,423 shares at $1 each
    Tiziana Life Sciences announced that its chief executive officer, Ivor Elrifi, purchased 321,423 common shares of the company on NASDAQ at $1.00 per share. The purchase raises his total holding to…
    globenewswire health · 1mo agoDealPositive↗ 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
  • Merck KGaA to receive up to €40 million in US tariff refunds for life science business through 2026
    Merck KGaA announced that it expects to receive tariff refunds for its life‑science division after a US Supreme Court ruling. The company estimates the refunds will total roughly €40 million and w…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Novo Nordisk board members disclose share vesting transactions
    Novo Nordisk issued a regulatory announcement on 6 August 2026 detailing share transactions by its board members, executives and related persons, as required by EU market abuse regulation. The fil…
    globenewswire health · 1mo agoRegulatoryNeutral↗ source
  • Centene reports strong enrollment growth but modest scale for its ICHRA offering
    Centene's chief executive Sarah London said the company's individual coverage health reimbursement arrangement (ICHRA) business is experiencing a strong enrollment growth rate, though the total num…
    Endpoints · 1mo agoEarningsPositive↗ 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