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  • Boston Scientific warns cyberattack will likely hit Q3 and full-year 2026 results
    Boston Scientific disclosed in a September 7 SEC filing that a cyberattack it suffered last month is expected to have a material impact on its third‑quarter and full‑year 2026 financial results. T…
    Fierce Biotech · 5d agoNegative↗ source
  • Guardant Health receives FDA clearance for Guardant360 CDx to guide AstraZeneca's Etcamah in breast cancer
    Guardant Health announced that the FDA has cleared its Guardant360 CDx test, which is designed to identify patients who may benefit from AstraZeneca's newly approved breast cancer therapy Etcamah.…
    Fierce Biotech · 5d agoApprovalPositive↗ source
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  • 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 · 5d 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 · 5d agoDealNeutral↗ source
  • BMC Medical recalls 20,160 Luna G3 APAP devices over firmware defect
    On July 15 2026 BMC Medical Co., Ltd. in Beijing reported to the FDA a recall of 20,160 Luna G3 APAP (Model LG3600) devices distributed in the United States because the installed firmware version G…
    fda recalls · 4d agoCRLNegative↗ 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 · 4d agoNeutral↗ 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 · 5d 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 · 6d agoPositive readoutPositive↗ source
  • Made Fresh Salads recalls ready-to-eat deli salads and cream cheese over possible Listeria contamination
    Made Fresh Salads Inc., based in Bay Shore, New York, announced a recall of all its ready-to-eat deli style salads and cream cheese. The recall was triggered by a potential contamination with List…
    fda recalls · 6d agoRegulatoryNegative↗ 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 · 7d 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 · 7d 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 · 7d 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 · 7d 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 · 7d agoApprovalPositive↗ source
  • Ionis secures FDA approval for zilganersen, a first treatment for Alexander disease
    Ionis Pharmaceuticals announced that the U.S. Food and Drug Administration has approved its antisense drug zilganersen for the treatment of Alexander disease, an ultra‑rare neurodegenerative disord…
    Fierce Biotech · 7d agoApprovalPositive↗ source
  • Menarini to launch Gan & Lee’s GLP-1 drug bofanglutide across Europe in $771 M partnership
    Italian firm Menarini Group has entered a licensing agreement with Chinese insulin producer Gan & Lee Pharmaceuticals to bring the GLP-1 compound bofanglutide to Europe. The deal includes an upfro…
    Fierce Biotech · 7d agoDealPositive↗ source
  • Novartis' Lp(a) drug pelacarsen fails to cut heart attack or stroke risk in phase 3 trial
    Novartis, in partnership with Ionis, completed the phase 3 Lp(a)Horizon trial of pelacarsen, an antisense oligonucleotide designed to lower lipoprotein(a) levels. The study enrolled more than 8,30…
    Fierce Biotech · 7d agoNegative readoutNegative↗ source
  • NeuShen Therapeutics raises over $80 million to advance three brain-health drug candidates
    NeuShen Therapeutics, a biotech with operations in Shanghai and Boston, announced it has closed a Series B financing round of more than $80 million. The capital will be used to move three clinical…
    Endpoints · 7d agoDealPositive↗ source
  • Truist sees biotech rebound as M&A hits $136B and XBI climbs 34% in H1
    Truist Securities says the biotech sector is regaining momentum after a prolonged post‑pandemic slowdown, driven by rising merger activity, returning venture capital and easing policy risks. The S…
    BioSpace · 7d agoPositive↗ source
  • Pfizer transfers Seagen ADC PF-08046031 to Medicus, adds $12M upfront payment amid acquisition doubts
    Pfizer has moved primary responsibility for an investigational antibody‑drug conjugate, PF‑08046031, to Medicus Pharma as part of its $43 billion Seagen acquisition. Under the license, Medicus wil…
    BioSpace · 7d agoDealNegative↗ source
  • Menarini secures European rights to Chinese GLP-1 obesity drug
    Menarini Group, a large family‑owned pharmaceutical company in Italy, has obtained the European commercial rights to a GLP‑1 agonist developed by China’s Gan & Lee. The agreement gives Menarini a…
    Endpoints · 7d agoDealPositive↗ source
  • MassBio and SCbio select 10 life science startups for Drive accelerator
    MassBio and SCbio announced that ten early‑stage life‑science companies have been chosen for the fall cohorts of the Drive accelerator program. The selection includes five biotech firms and five te…
    BioSpace · 7d agoPositive↗ source
  • Thiel-backed Lindus Therapeutics sells CRO division and shifts focus to acquiring drug assets
    Lindus Therapeutics, a transatlantic startup backed by Peter Thiel, announced the sale of its contract research organization (CRO) arm. The company, previously positioning itself as an “anti‑CRO,”…
    Endpoints · 7d agoDealNeutral↗ source
  • Foods Alive recalls organic moringa leaf powder over possible Salmonella contamination
    Foods Alive Inc. of Angola, Indiana announced a recall of its 8‑ounce organic moringa leaf powder because of a potential Salmonella contamination. The product was shipped nationwide between Jan 27…
    fda recalls · 7d agoCRLNeutral↗ source
  • Ultragenyx’s Angelman therapy fails Phase 3, stock drops over 43% and company announces strategic review
    Ultragenyx reported that its investigational Angelman syndrome drug apazunersen did not meet the primary cognitive endpoints in a Phase 3 trial. The lack of efficacy means the therapy will not prov…
    BioSpace · 8d agoNegative readoutNegative↗ source