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1,488 stories matching this filter · ← front page

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  • Mezzetta voluntarily recalls 32-oz Golden Greek Peperoncini after pest contaminant found in jar
    G. L. Mezzetta Inc. announced a voluntary recall of its 32‑oz Golden Greek Peperoncini after a video showed a pest contaminant in a jar. The recall is limited to lot 720106 (SKU 10106328). The com…
    fda recalls · 25d agoRegulatoryNeutral↗ source
  • Adicet Bio's off-the-shelf CAR-T therapy shows lupus remission in early Phase 1 trial
    Adicet Bio reported that its off-the-shelf CAR-T product prula-cel induced remission in more than half of lupus patients enrolled in a small Phase 1 study. One year after a single infusion, 12 of…
    Fierce Biotech · 26d agoPositive readoutPositive
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  • Genentech signs $55M upfront deal with AI firm Earendil Labs to develop bispecific cancer antibodies, potential total value over $1.5B
    Genentech announced a partnership with AI‑driven Earendil Labs that includes a $55 million upfront payment and could exceed $1.5 billion when development, regulatory and sales milestones are met. T…
    BioSpace · 26d agoDealPositive↗ source
  • Carvykti shows 5-year survival in half of multiple myeloma patients in Phase 2 study
    Johnson & Johnson and Legend Biotech reported that 10 of the 20 multiple myeloma patients treated with a single dose of Carvykti remained alive after a median follow‑up of 60.7 months, representing…
    BioSpace · 26d agoPositive readoutPositive↗ source
  • Novo signs $1.3 billion deal with Nanexa to add long-acting injectables for obesity and diabetes
    Novo has entered a licensing agreement with Nanexa, valued at about 1.17 billion euros, to use Nanexa’s PharmaShell platform for its obesity and type‑2 diabetes medicines. The PharmaShell technolo…
    Fierce Biotech · 26d agoDealPositive↗ source
  • Genentech signs $1.5 billion bispecific antibody deal with Earendil Labs
    Genentech, Roche's US subsidiary, announced a licensing agreement with Earendil Labs to discover and develop multiple bispecific antibodies aimed at oncology. The agreement provides a $55 million…
    Fierce Biotech · 26d agoDealPositive↗ source
  • Biomanufacturers Redesign Processes to Blend Emergency Vaccine Readiness with Commercial Flexibility
    Manufacturers are overhauling their production methods to simultaneously improve rapid vaccine deployment for future health crises and maintain flexible, commercially viable manufacturing networks…
    BioSpace · 26d agoNeutral↗ source
  • ADARx raises $446 million in one of 2026's largest biotech IPOs as City Therapeutics plans its own listing
    ADARx Pharmaceuticals completed an initial public offering that raised about $446.3 million, exceeding the company’s original target. The shares were priced at $17 each, with 26.25 million shares…
    BioSpace · 26d agoDealPositive↗ source
  • ADARx upsizes Nasdaq IPO to $446M as City Therapeutics eyes public listing
    ADARx Pharmaceuticals, a San Diego-based RNA biotech, completed a Nasdaq initial public offering this morning, selling 26.3 million shares at $17 each. The offering generated gross proceeds of abo…
    Fierce Biotech · 26d agoDealPositive↗ source
  • Lundbeck plans US headquarters move to Boston to boost neuroscience R&D
    Lundbeck, a Danish pharmaceutical company focused on neuroscience, announced it will relocate its U.S. operations to Boston. The move is part of a broader strategy to concentrate R&D on increasing…
    Fierce Biotech · 26d agoNeutral↗ source
  • Boston Scientific recalls Imager II angiographic catheters over tip detachment risk
    Boston Scientific has issued a recall of its Imager II Angiographic Catheters after a manufacturing problem that can cause the catheter tip to detach during use. The FDA classified the recall as t…
    fda medwatch · 26d agoCRLNegative↗ source
  • NIH deputy director Nicole Kleinstreuer leads push to cut animal testing with new policies
    NIH has spent the past 18 months accelerating policies aimed at reducing the use of animals in research. The effort is being directed by Dr. Nicole Kleinstreuer, the agency’s deputy director for p…
    Fierce Biotech · 26d agoRegulatoryPositive↗ source
  • Indivior ends Addex PAM collaboration as it prepares for Supernus merger
    Indivior Pharmaceuticals has terminated its long‑standing partnership with Addex Therapeutics that focused on developing positive allosteric modulators (PAMs) for addiction treatment. The collabor…
    Fierce Biotech · 26d agoDealNeutral↗ source
  • Jury awards Nektar $90 million in damages after lawsuit over broken rezpeg partnership with Eli Lilly
    A jury in a US court has ordered Eli Lilly to pay Nektar Therapeutics $90 million after finding the pharma giant breached their collaboration on the experimental autoimmune drug rezpeg. Nektar and…
    BioSpace · 26d agoNegative↗ source
  • FDA approves Eli Lilly’s weekly insulin Onswik for U.S. patients, expanding competition with Novo
    The U.S. Food and Drug Administration has cleared Eli Lilly’s weekly insulin product, Onswik, for use in American patients. This marks the drug’s fourth global approval after earlier clearances in…
    BioSpace · 27d agoApprovalPositive↗ source
  • Kyverna reports one-year mobility gains and safety for CAR-T miv-cel in stiff-person syndrome, bolstering FDA filing plans
    Kyverna Therapeutics presented data from its Phase 2 KYSA-8 trial of miv-cel, a CAR-T therapy aimed at stiff-person syndrome (SPS). The study followed 26 patients for one year. At the one-year mar…
    BioSpace · 27d agoPositive readoutPositive↗ source
  • Acadia misses mark in Alzheimer’s but concludes phase 3 ‘absolutely worth’ pursuing
    Acadia Pharmaceuticals’ phase 2 Alzheimer’s disease trial has missed its primary endpoint, but the company and analysts alike saw enough encouraging signals to support the continuation of a phase 3…
    Fierce Biotech · 27d agoNegative readoutNegative↗ source
  • Roche signs up to $2 billion partnership with Atavistik to develop cardiometabolic drugs
    Roche announced a partnership with Atavistik Bio, a biotech focused on hematology, to pursue new small-molecule treatments for cardiovascular, renal and metabolic conditions. The agreement provide…
    BioSpace · 27d agoDealPositive↗ source
  • Eli Lilly earmarks up to $3.25 billion for partnership with InnoCare Pharma
    Eli Lilly announced an upfront payment of $100 million to Beijing‑based InnoCare Pharma to start work on drug candidates for five targets that have critical unmet medical needs. The agreement also…
    BioSpace · 27d agoDealNeutral↗ source
  • Radioligand therapy gains momentum as experts discuss expanding patient impact
    In a recent episode of the Denatured podcast presented by Curium, host Jennifer Smith-Parker spoke with Mike Patterson, CEO North America, and Sabine Brookman-May, Vice President and Head of Global…
    BioSpace · 27d agoPositive↗ source
  • Henlius Biotech signs $440 million deal with Amberstone to develop T-cell engagers
    Henlius Biotech, a subsidiary of Fosun Pharma, announced a licensing agreement with California‑based Amberstone Biosciences valued at up to $440 million. The partnership will focus on creating anti…
    Fierce Biotech · 27d agoDealPositive↗ source
  • Roche signs $2 billion deal with Atavistik to discover allosteric cardiovascular-renal-metabolic drugs
    Roche announced a partnership with Cambridge-based biotech Atavistik Bio to develop allosteric small-molecule therapies for cardiovascular, renal and metabolic diseases. The agreement includes an u…
    Fierce Biotech · 27d agoDealPositive↗ source
  • Eli Lilly commits $100M upfront in new five-target partnership with China's InnoCare
    Eli Lilly has agreed to pay $100 million upfront and in the near term to Chinese biotech InnoCare Pharma as part of a five‑target drug discovery partnership. The agreement also provides for up to $…
    Fierce Biotech · 27d agoDealPositive↗ source
  • FDA warns Houston compounding pharmacy of unsanitary GLP-1 production risking contamination
    FDA issued a warning letter to Empower Clinic Services, operating as Empower Pharmacy, after inspectors found unsanitary conditions at its Houston compounding site. Inspectors observed that the ph…
    BioSpace · 27d agoRegulatoryNegative↗ source
  • Acadia’s Alzheimer’s psychosis drug misses primary goal but advances on secondary data
    Acadia Pharmaceuticals reported that its investigational drug remlifanserin failed to meet the primary endpoint in the Phase 2 portion of the RADIANT trial for Alzheimer’s disease psychosis. The t…
    BioSpace · 27d agoNegative readoutNeutral↗ source