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1,804 stories matching this filter · ← front page

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  • Rezdiffra Beats Wall Street Forecasts as MASH Market Expands
    Rezdiffra, a drug candidate targeting metabolic dysfunction‑associated steatohepatitis (MASH), is outperforming analysts' expectations according to recent commentary. The optimism comes as the mar…
    Endpoints · 3mo agoPositive↗ source
  • Inhibrx reports 44% response rate when paired with Keytruda in head-and-neck cancer Phase 2 trial
    Inhibrx Biosciences said its experimental agent INBRX-106 boosted the activity of Merck's Keytruda in a Phase 2 study of a head-and-neck cancer. The combination achieved a 44% overall response rate…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
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fda recalls67
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Infectious Disease444
  • GSK partners with Sino Biopharma to expand access to hepatitis B drug bepirovirsen in China
    GSK announced a marketing agreement with Sino Biopharmaceutical to distribute its experimental hepatitis B therapy bepirovirsen in China. Sino's subsidiary will purchase a supply of the drug and u…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Daiichi Sankyo targets $15 billion in oncology sales by 2030 as it expands ADC franchise
    Daiichi Sankyo released a new five‑year business plan that sets a goal of nearly $15 billion in oncology revenue by 2030. The target is part of a broader ambition to push total company sales past 3…
    Endpoints · 3mo agoNeutral↗ source
  • Inhibrx reports combo of Keytruda and INBRX-106 reduces tumors more than Keytruda alone in metastatic head cancer
    San Diego biotech Inhibrx says its experimental drug INBRX-106, when added to Merck's immunotherapy Keytruda, led to a higher rate of tumor shrinkage than Keytruda by itself. The observation comes…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Braveheart Bio's Hengrui-licensed cardiac therapy shows positive mid-stage trial results
    Braveheart Bio announced that its heart muscle therapy, licensed from Jiangsu Hengrui Pharmaceuticals, has achieved a positive outcome in a Phase 2 trial. The mid-stage study met its primary endpo…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Biotech layoffs slow as companies like BioNTech cut nearly 1,900 jobs amid market pressures
    The biotech sector has seen more than 40 layoff announcements through the end of April 2026, a decline from the over 50 rounds reported in the final months of 2025. Analysts had expected the pace t…
    BioPharma Dive · 3mo agoLayoffsNegative↗ source
  • European regulators approve Fractyl Health's first GLP-1 gene therapy clinical trial
    European regulators have given the green light for Fractyl Health, a biotech near Boston, to begin its first human study of a GLP-1 gene therapy. The therapy aims to provide a one-time treatment t…
    Endpoints · 4mo agoRegulatoryPositive↗ source
  • Specialized logistics critical for delivering next-generation cell and gene therapies
    The article explains that personalized medicines such as cell and gene therapies are transforming treatment for rare diseases and cancers. Unlike conventional drugs, these therapies are often made…
    BioPharma Dive · 4mo agoNeutral↗ source
  • Biopharma capacity crunch shifts focus to ready-now manufacturing hubs like Middlesex County, NJ
    Demand for biopharma manufacturing, especially cell and gene therapies, is growing faster than the ability to build new GMP-ready facilities, which can take years to complete. To keep pace, compan…
    BioPharma Dive · 4mo agoNeutral↗ source
  • Optum Rx Announces Transparent Pharmacy Model Set to Launch in 2027
    Optum Rx, a unit of UnitedHealth Group, introduced a new pharmacy benefit model that promises clear fee structures for its customers. The model is designed to give members visibility into the full…
    Endpoints · 3mo agoPositive↗ source
  • Novo Nordisk secures biotech partner for Parkinson's cell therapy as GSK signs hepatitis B drug deal in China
    Novo Nordisk has found a biotech partner to advance its early‑stage Parkinson's disease cell therapy, giving the program a new development home. GSK disclosed a commercial agreement to sell its he…
    Endpoints · 3mo agoDealNeutral↗ source
  • Endpoints Weekly highlights biotech company models, a quirky startup story, and earnings season updates
    The latest edition of Endpoints Weekly introduces a look at emerging biotech company structures, noting how new models are reshaping the industry. It also features a light‑hearted piece about a st…
    Endpoints · 4mo agoNeutral↗ source
  • Lilly adds $4.5 billion to Indiana manufacturing to boost weight-loss drug supply
    Eli Lilly & Co. announced an additional $4.5 billion investment in two of its three manufacturing sites in Lebanon, Indiana. The funding is aimed at expanding capacity for both its genetic therapie…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Trump reportedly plans to dismiss FDA Commissioner Marty Makary
    Multiple media outlets report that President Donald Trump is considering removing FDA Commissioner Marty Makary from his post. The reports say the decision has not been finalized and could still be…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • WSJ reports Trump plans to fire FDA Commissioner Marty Makary, decision not yet final
    The Wall Street Journal reported that President Donald Trump is considering removing FDA Commissioner Marty Makary from his post. The report said the administration has not yet made a final decisi…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • Daiichi Sankyo writes off $950 million after abandoning ADC manufacturing plan
    Daiichi Sankyo announced it will abandon its planned antibody-drug conjugate (ADC) manufacturing facility. The company said the decision follows a serious over-estimate of third-party demand for AD…
    Endpoints · 4mo agoEarningsNegative↗ source
  • FDA delays Leqembi decision; Artiva raises $300M; Pharvaris prices offering
    🗓️ FDA delays subcutaneous Leqembi decision: Originally slated for later this month, the decision date now falls on August 24, Biogen and Eisai said. The agency asked for more information from ...
    Endpoints · 4mo ago↗ source
  • FDA to reevaluate spurned cell therapy; Under-the-skin Leqembi review extended
    Pierre Fabre claims to now be “aligned” with U.S. regulators on the path forward for a twice-rejected treatment. Elsewhere, Argenx swapped CEOs and Blackstone made a $250 million biotech investment.
    BioPharma Dive · 4mo ago↗ source
  • Lilly, Gilead lead pharma’s M&A boom
    Deal volume in 2026 is substantially outpacing last year, and activity is being driven by interest in cancer and autoimmune disease drugs.
    BioPharma Dive · 4mo ago↗ source
  • 'Pharma, not really’: Top young AI talent shuns careers at big drugmakers
    RIO DE JANEIRO — Mazdak Abulnaga should be the poster child for the type of employee pharma companies want to hire this year. Abulnaga, a 33-year-old postdoctoral fellow at MIT and Harvard Medical…
    Endpoints · 4mo ago↗ source
  • Natalie Holles' next move after Third Harmonic shutdown; Mark Alles passes the torch at ADC biotech
    → It didn’t take long for Natalie Holles to rebound after the decision to wind down operations at her previous company. She has replaced Elisabet de los Pinos as CEO of ...
    Endpoints · 4mo ago↗ source
  • Capricor sues Nippon Shinyaku over Duchenne drug 'pricing flaw' and launch prep
    Capricor Therapeutics said Thursday it has filed a lawsuit against Nippon Shinyaku over a distribution and commercialization agreement for deramiocel, a cell therapy candidate for Duchenne muscular…
    Endpoints · 4mo ago↗ source
  • Odyssey raises more than $300M as biotech goes public
    Odyssey Therapeutics pulled together $279 million from its initial public offering, the autoimmune disease drug developer said Thursday night. Odyssey began trading on the Nasdaq on Friday. The bio…
    Endpoints · 4mo ago↗ source
  • Odyssey, on second try, snags $279M in an IPO
    After withdrawing its initial filing last year, the immune drugmaker rebounded and added to a recent run of sizable new biotech stock offerings — while boosting its haul even higher through a concu…
    BioPharma Dive · 4mo ago↗ source