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218 stories matching this filter · ← front page

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  • FDA’s new leadership aims to restore reliability, but each application remains judged on its data
    The FDA’s current leadership is working to rebuild the agency’s reputation for reliability, integrity and transparency after a turbulent period under former commissioner Marty Makary. Recent actio…
    BioSpace · 13h agoRegulatoryNeutral↗ source
  • Boehringer Ingelheim pauses Phase 1 study of oral candidate BI 3031185 after safety event
    Boehringer Ingelheim has placed a Phase 1 study of its oral candidate BI 3031185 on hold after a safety event was identified. The trial, run in Japan with healthy volunteers, was assessing tolerab…
    BioSpace · 5h agoCRLNegative↗ source
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Psychiatry & CNS741
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Endocrinology & Metabolism395
Infectious Disease373
  • Handshakes in the ER: A simple gesture can ease patient anxiety
    An emergency medicine resident at Northwestern University recounts a recent shift where a patient faced a suspected oncologic emergency. The physician introduced herself with a handshake to the pat…
    STAT · 8h agoPositive↗ source
  • Nurse practitioner students struggle to find clinical preceptors, often paying thousands
    Nurse practitioner graduate programs require students to complete at least 500 hours of supervised patient care with a licensed preceptor. Across the United States, a shortage of qualified precepto…
    STAT · 8h agoNegative↗ source
  • Roche, Eli Lilly net FDA approval for first-of-its-kind Alzheimer’s biomarker blood test
    Roche and Eli Lilly have won FDA clearance for their latest Alzheimer’s disease diagnostic.
    Fierce Biotech · 9h ago↗ source
  • Merck’s Ebola vaccine rolled out in the Democratic Republic of Congo
    Scientists have begun administering Merck’s Ebola vaccine in the Democratic Republic of Congo as part of ongoing outbreak response efforts. The vaccine, previously used in emergency settings, is b…
    STAT · 3d agoPositive↗ source
  • Novo Nordisk launches Phase 3 trial of lower maintenance doses of oral Wegovy for obesity
    Novo Nordisk has begun a Phase 3, placebo-controlled study called OASIS 5 to evaluate two lower oral doses of its GLP-1 weight-loss drug Wegovy (semaglutide) in people who are obese or overweight.…
    BioSpace · 3d agoCRLNeutral↗ source
  • New study shows focal therapy matches surgery and radiation survival while reducing side effects in localized prostate cancer
    Physicians remain split over focal therapy for localized prostate cancer, a technique that targets MRI‑visible lesions with heat, cold, or other energy sources instead of removing the entire gland.…
    STAT · 3d agoPositive readoutNeutral↗ source
  • Regeneron’s ultra-rare bone disorder drug receives U.S. approval after 30-year development
    Regeneron Pharmaceuticals announced that its therapy for an ultra-rare condition in which bone forms in soft tissue has been approved by the U.S. Food and Drug Administration. The disease, sometim…
    STAT · 4d agoApprovalPositive↗ source
  • FDA clears Vitestro's Aletta, first robotic blood draw device for U.S. clinics
    The U.S. Food and Drug Administration has granted clearance to Vitestro's Aletta, making it the first standalone robotic system approved to draw blood without direct human handling. Aletta can per…
    Fierce Biotech · 4d agoApprovalPositive↗ source
  • Novo Nordisk leads early in oral obesity market, but analysts doubt lasting advantage
    Novo Nordisk's oral formulation of Wegovy generated DKK 3.22 billion (about $496 million) in revenue in the second quarter of 2026, far outpacing Eli Lilly's newly approved oral weight‑loss pill Fo…
    BioSpace · 5d agoNeutral↗ source
  • Tolerance Bio secures up to $260 M for thymus‑targeting fusion protein, moves into Phase 2 trials
    Tolerance Bio, a Philadelphia biotech founded in October 2024, has signed a licensing agreement to acquire rights to NeoImmuneTech’s long‑acting IL‑7 fusion protein, efineptakin alfa, for up to $26…
    Fierce Biotech · 5d agoDealPositive↗ source
  • AI fuels a parallel, unregulated medical ecosystem outside traditional care
    Arya Rao, a Harvard‑MIT M.D.-Ph.D. candidate, and Marc Succi, a Harvard radiology professor, argue that financial incentives are pulling major AI firms into health care, creating a shadow system se…
    STAT · 5d agoNegative↗ source
  • Amylyx reports promising GLP-1 blocker results while Summit faces survival setbacks and Definium shows anxiety therapy benefit
    Amylyx said its investigational GLP-1 blocker avexitide cut the combined rate of level 2 and level 3 hypoglycemic events by about 55% in patients with post‑bariatric hypoglycemia, beating analyst e…
    BioSpace · 5d agoNeutral↗ source
  • Amgen ends $500M Crohn’s disease collaboration with TScan, but TScan says pipeline strategy stays on track
    Amgen has terminated its collaboration with TScan Therapeutics that was aimed at Crohn’s disease, ending a deal that could have delivered up to $500 million in milestones. The partnership began in…
    Fierce Biotech · 4d agoDealNeutral↗ 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 · 5d agoLayoffsNegative↗ source
  • Immunologist Liz Marnik, raised unvaccinated, now advocates for science and empathy in vaccine discussions
    Immunologist Liz Marnik grew up in a household that rejected vaccines, and she herself went without any immunizations into adulthood. At age 23 she visited a travel clinic and received all standar…
    STAT · 5d agoPositive↗ source
  • Amylyx avexitide cuts serious low blood sugar events by 55% in Phase 3 trial for post bariatric hypoglycemia
    Amylyx Pharmaceuticals reported that its experimental drug avexitide significantly reduced the frequency of serious low blood sugar episodes in a Phase 3 study of patients with post‑bariatric hypog…
    STAT · 6d agoPositive readoutPositive↗ source
  • Craif raises $33M to expand its urine-based pancreatic cancer test
    AI biopharma Craif announced a $33 million Series D financing, bringing its total capital raised to $88 million. The funding will be used to scale research on its urine-based microRNA test, miSign…
    Fierce Biotech · 6d agoDealNeutral↗ source
  • Amylyx reports positive pivotal trial results for drug targeting post-bariatric hypoglycemia
    Amylyx announced that its experimental therapy achieved statistically significant improvement in patients who experience severe hypoglycemia after bariatric surgery. The company said the pivotal t…
    STAT · 5d agoPositive readoutPositive↗ source
  • Harvard researchers keep brain organoids alive for five years, tracking development
    A study published in Nature describes how researchers at Harvard University grew a human brain organoid from a blood sample and kept it alive in the lab for five years. During the five-year period…
    Fierce Biotech · 6d agoPositive↗ source
  • FDA approves Zenbexus for multiple myeloma as NSAI looks to sell MDR notified body unit
    The U.S. Food and Drug Administration has granted approval for Zenbexus to be used in the treatment of multiple myeloma, marking a new therapeutic option for patients with this blood cancer. The a…
    raps · 7d agoApprovalPositive↗ source
  • Amylyx's avexitide halves hypoglycemia episodes in phase 3 trial for post‑bariatric patients
    Amylyx Pharmaceuticals reported that its GLP‑1 receptor antagonist avexitide significantly reduced dangerous blood‑sugar drops in a phase 3 study. The double‑blind Lucidity trial enrolled 78 indiv…
    Fierce Biotech · 6d agoPositive readoutPositive↗ source
  • AstraZeneca halts late-stage lung cancer trial of volrustomig after disappointing interim results
    AstraZeneca announced it is stopping a Phase 3 study of its bispecific antibody volrustomig in metastatic non-small cell lung cancer after an interim analysis showed the drug is unlikely to meet it…
    BioSpace · 7d agoNegative readoutNegative↗ source
  • AstraZeneca halts late-stage lung cancer trial of volrustomig after disappointing interim results
    AstraZeneca said it is ending its Phase 3 eVOLVE-Lung02 trial that evaluated the bispecific antibody volrustomig combined with chemotherapy as a first-line option for metastatic non-small cell lung…
    BioSpace · 7d agoNegative readoutNegative↗ source