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3,102 stories matching this filter · ← front page

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STAT1172Endpoints887BioPharma Dive342BioSpace307Fierce Biotech290onclive165raps104globenewswire health73
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  • 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 · 8h 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…
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fda recalls67
fda medwatch60
fda press38
1147
Psychiatry & CNS866
Ophthalmology494
Pain478
Endocrinology & Metabolism471
Infectious Disease444
Fierce Biotech · 16h 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 · 23h 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 cardiovascular trials of inflammation-targeting drug ziltivekimab
    Novo Nordisk announced it is halting the HERMES and ATHENA cardiovascular trials of its experimental drug ziltivekimab, which was intended to lower inflammation to improve heart health. A data mon…
    STAT · 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
  • ADA panel still reviewing expulsions from June conference, further actions possible
    The American Diabetes Association released top‑line findings on Sept. 1 from an internal panel tasked with reviewing the June 5 expulsion of five members at its New Orleans conference. The full re…
    STAT · 1d agoNegative↗ source
  • Novartis and Ionis's pelacarsen fails to cut heart events despite lowering Lp(a) levels
    Novartis and Ionis reported that pelacarsen, an RNA therapy aimed at lowering lipoprotein(a), did not reduce major cardiovascular events in a Phase 3 trial of over 8,000 patients. The study compare…
    BioPharma Dive · 2d agoNegative readoutNegative↗ 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
  • STAT readers weigh in on MD vs DO training, AI accountability and surrogacy in medicine
    STAT’s First Opinion platform invites letters that respond to its essays, and a recent submission addresses several hot topics in health care. The writer acknowledges the bias that osteopathic gra…
    STAT · 3d agoNeutral↗ source
  • Novartis' experimental heart drug pelacarsen fails pivotal Phase 3 trial
    Novartis announced that its experimental cardiovascular therapy, pelacarsen, did not meet its primary endpoints in the Phase 3 HORIZON trial. The study compared the drug to placebo and found no red…
    STAT · 3d agoNegative readoutNegative↗ source
  • Ionis receives FDA approval for Zanvastro, the first treatment for Alexander disease, as Pfizer partners on new ADC program
    The U.S. Food and Drug Administration approved Zanvastro, marking the first approved medicine for the rare and often fatal neurological disorder Alexander disease. Developed by Ionis Pharmaceutical…
    BioPharma Dive · 4d agoApprovalPositive↗ 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
  • AbbVie’s dual-acting myeloma drug etentamig meets main Phase 3 goal, showing longer progression-free survival
    AbbVie announced that its bispecific antibody etentamig achieved the primary endpoint in a Phase 3 trial for patients with multiple myeloma who have progressed after two or more prior therapies. Th…
    BioPharma Dive · 4d agoPositive readoutPositive↗ source
  • Licensing deals with Chinese biotech stay strong as big pharma pours $550M+ into cancer and obesity pipelines
    Western drug developers continue to sign licensing agreements with Chinese biotechnology firms at a steady pace, according to recent data visualizations. More than 100 such deals have been announc…
    BioPharma Dive · 4d agoDealNeutral↗ source