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1,649 stories matching this filter · ← front page

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  • Expanding its biopharma plans, Anthropic looks for a life-sciences dealmaker
    Anthropic's newest job posting confirms the company's biotech dealmaking ambitions. The San Francisco tech company is hiring for a corporate development lead in biopharma to “source and execute acq…
    Endpoints · 18m ago↗ source
  • Krazati withdrawal completed; Wegovy trial meets endpoint for kids ages 6 to 12
    Plus news about Structure Therapeutics, Cloverleaf Bio and Windward Bio. FDA finalizes Krazati withdrawal: Regulators officially finalized the drug’s withdrawal in second-line colorectal cancer las…
    Endpoints · 53m ago↗ source
  • AZ's R&D chief Barr touts internal 'science success story' after IL-33 antibody's stellar showing in COPD
    With a detailed data drop that AstraZeneca’s R&D chief describes as an internal “science success story,” the British Big Pharma has secured an FDA priority review for what it believes could become…
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Fierce Biotech · 5h ago↗ source
  • FDA approves AstraZeneca’s Etcamah, opening ctDNA-guided treatment paradigm in breast cancer
    In a rare divergence from its own expert panel, the FDA has granted accelerated approval to AstraZeneca’s camizestrant, turning a contentious regulatory review into a landmark win that opens a new…
    Fierce Biotech · 6h ago↗ source
  • Spyre's 3-pronged IBD strategy on track as IL-23 antibody rounds off trio of phase 2 wins
    Spyre's three-pronged approach to inflammatory bowel disease continues to pay off, with the biotech's anti-IL-23 antibody notching a phase 2 win.
    Fierce Biotech · 6h ago↗ source
  • Pharvaris' latest phase 3 win builds case for HAE drug with FDA verdict pending
    Pharvaris’ deucrictibant has tasted success in a second phase 3 study, strengthening the case for the therapy to treat hereditary angioedema patients as the Swiss biotech awaits an FDA approval dec…
    Fierce Biotech · 6h ago↗ source
  • Bristol Myers’ pivotal CAR-T multiple myeloma trial hits primary endpoint
    A pivotal trial of Bristol Myers Squibb’s GPRC5D-directed CAR-T cell therapy has hit its primary endpoint, furthering the drugmaker’s efforts to challenge Johnson & Johnson for the post-BCMA multip…
    Fierce Biotech · 7h ago↗ source
  • Boston Scientific recalls spinal cord implant in wake of more than 1k serious injuries
    Boston Scientific has issued another recall, this time for its spinal cord implant used to treat pain.
    Fierce Biotech · 7h ago↗ source
  • Inhibrx CEO says progression-free survival data leave ‘no question’ about OX40 agonist’s durability
    Inhibrx Biosciences’ CEO has argued that the 9.6 months of progression-free survival demonstrated by its OX40 agonist in a phase 2 study has proven the therapy’s durability in treating head and nec…
    Fierce Biotech · 15h ago↗ source
  • Novartis reports Phase 3 pelacarsen trial fails to improve cardiovascular outcomes
    Novartis said its late-stage Phase 3 trial of the antisense drug pelacarsen did not show a benefit in reducing major cardiovascular events compared with placebo. The result adds to a recent string…
    Endpoints · 1d agoNegative readoutNegative↗ source
  • FDA grants accelerated approval to AstraZeneca's oral SERD for breast cancer despite advisory panel opposition
    FDA granted accelerated approval to AstraZeneca's oral selective estrogen receptor degrader, Camizestrant, for a specific group of breast cancer patients. The approval was issued on Friday even th…
    Endpoints · 22h agoApprovalPositive↗ source
  • Novo Nordisk abandons two phase 3 trials of ziltivekimab, dimming blockbuster hopes
    Novo Nordisk announced it is terminating two late‑stage phase 3 studies of its IL‑6 ligand antibody ziltivekimab. The Hermes and Athena trials enrolled about 4,900 and 673 patients with heart fail…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • Novo Nordisk halts two late-stage ziltivekimab heart trials after futility finding
    Novo Nordisk announced it has stopped work early on two additional late-stage clinical studies of its IL-6 inhibitor ziltivekimab, which was being evaluated for heart disease. The decision followe…
    Endpoints · 1d agoNegative readoutNegative↗ source
  • Claret Capital Partners raises €575 million Fund IV to boost European biotech lending
    Claret Capital Partners, a European investment firm, announced that its fourth fund has closed at €575 million. The firm said a significant share of the capital will be deployed as loans to life-s…
    Endpoints · 1d agoDealNeutral↗ source
  • BrainChild Bio masterminds $116M series A for CAR-T's pivotal push in pediatric brain cancer
    A startup spawned from Seattle Children’s Hospital has raised a $116 million series A to advance cell therapies for devastating childhood brain tumors.
    Fierce Biotech · 1d agoNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 17h agoLayoffsNegative↗ source
  • Boston Scientific cyberattack likely to have ‘material impact’ on financial results
    The recent cyberattack on Boston Scientific is looking more serious than the medtech major first thought, with the company predicting a possible hit to its third-quarter and full-year results.
    Fierce Biotech · 1d ago↗ source
  • Guardant wins FDA nod for diagnostic guiding use of AstraZeneca’s Etcamah
    Hot on the heels of the approval for AstraZeneca’s breast cancer drug Etcamah, Guardant Health has been given the green light for its companion diagnostic.
    Fierce Biotech · 1d ago↗ source
  • ADARx, backed by AbbVie, files for IPO to fund clinical-stage siRNA programs
    ADARx Pharmaceuticals, a San Diego biotech supported by AbbVie, announced plans to pursue an initial public offering. The company says most of the IPO proceeds will be used to advance three clinic…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Roivant’s inhaled pulmonary hypertension drug mosliciguat shows strong Phase 2 results
    Roivant invested $14 million in Bayer's inhaled soluble guanylate cyclase activator mosliciguat after a $294 million biobucks agreement in 2024, and promptly advanced the candidate into a Phase 2 s…
    Fierce Biotech · 2d agoPositive readoutPositive↗ source
  • Novartis pauses CAR-T trials after three patient deaths
    Novartis announced a pause on its experimental CAR-T therapy after three patients died while receiving the treatment. The company said it will halt ongoing immunology and neuroscience studies relat…
    Endpoints · 3d agoRegulatoryNegative↗ source
  • ADARx Pharmaceuticals, backed by AbbVie, files for IPO with three RNAi drugs in clinical trials
    ADARx Pharmaceuticals, an RNA interference biotech based in San Diego, disclosed its plan to go public in a Friday night SEC filing. The company aims to capitalize on the current momentum in biotec…
    Endpoints · 3d agoDealNeutral↗ source
  • AbbVie’s etentamig shows strong survival and response gains in Phase 3 multiple myeloma trial
    AbbVie reported that its investigational bispecific T‑cell engager, etentamig, significantly reduced the risk of disease progression or death in a Phase 3 study of patients with relapsed or refract…
    BioSpace · 4d agoPositive readoutPositive↗ source
  • Funding shortfall threatens progress of new Ebola vaccine candidates
    A rapidly expanding Ebola outbreak in Africa has spurred multiple groups to accelerate vaccine development. The effort is being coordinated by a key global health organization, but the group is fa…
    Endpoints · 4d agoNegative↗ source
  • Ionis secures FDA approval for zilganersen, its first solo neurology therapy for Alexander disease
    Ionis Pharmaceuticals announced that the U.S. Food and Drug Administration has granted approval to its investigational RNA‑based drug zilganersen for the treatment of Alexander disease, a rare neur…
    Endpoints · 4d agoApprovalPositive↗ source