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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 · 5d 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 · 4d agoRegulatoryNegative↗ source
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  • BioNTech appoints former Sobi chief Guido Oelkers as new CEO
    BioNTech has filled its long-vacant chief executive position after a six-month search. The board selected Guido Oelkers, Ph.D., who most recently led Swedish pharmaceutical company Sobi. At Sobi,…
    Fierce Biotech · 4d agoNeutral↗ 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 · 4d 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 · 4d agoDealPositive↗ source
  • Tarsus to acquire Alkeus for $450 million, adding phase-3 retinal drug and oral Stargardt candidate
    Tarsus Pharmaceuticals announced it will buy Alkeus Pharmaceuticals in a transaction valued at $450 million. The deal consists of $270 million in cash and $180 million of Tarsus common stock, givi…
    Fierce Biotech · 4d agoDealPositive↗ source
  • FDA approves first drug for type 1 narcolepsy and greenlights mRNA flu vaccine; AstraZeneca and BMS deny merger talks
    The U.S. Food and Drug Administration has granted approval for the first therapy specifically targeting type 1 narcolepsy, marking a milestone for patients with this rare sleep disorder. In a sepa…
    raps · 5d agoApprovalPositive↗ 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 · 4d 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 · 4d 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 · 4d 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 · 4d 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 · 4d 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 · 4d 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 · 4d agoNeutral↗ source
  • BioVie’s Parkinson drug data prompts 50% stock drop as company shifts to composite endpoint
    BioVie announced phase 2 results for its experimental Parkinson’s therapy bezisterim, saying the data suggest a meaningful advance in treating the disease. Investors reacted sharply, wiping out ro…
    Fierce Biotech · 4d agoNegative readoutNegative↗ 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 · 5d agoPositive↗ source
  • Braveheart Bio raises $382.5M in IPO to fund phase 3 trial of cardiac drug
    Braveheart Bio, a San Francisco biotech, completed an IPO that raised $382.5 million, exceeding its original target. The company increased the share count to 21.2 million and set the price at $18…
    Fierce Biotech · 5d agoDealPositive↗ 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 · 5d 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 · 5d agoNeutral↗ source
  • FDA says MDUFA VI will prioritize review consistency and domestic focus over faster timelines
    FDA officials explained that the next Medical Device User Fee Amendments, known as MDUFA VI, will aim to improve consistency in the review process. The agency said the new framework will emphasize…
    raps · 5d agoRegulatoryNeutral↗ 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 · 4d 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 · 5d 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 · 4d 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 · 4d 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 · 5d agoRegulatoryNeutral↗ source