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163 stories matching this filter · ← front page

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allOncology6027Rare Disease1434Cardiology1089Hematology1024Immunology1000Vaccines902Pulmonology
  • Ultragenyx secures FDA approval for Glenglycos, first gene therapy for GSD Ia
    Ultragenyx announced FDA approval of Glenglycos, a one-time gene therapy for glycogen storage disease type Ia, a rare genetic disorder. The therapy delivers a functional gene to the liver to resto…
    BioPharma Dive · 3h agoApprovalPositive↗ source
  • Meet Aletta: The first FDA approved robotic blood draw device
    The FDA has approved Vitestro’s Aletta as the first standalone robotic device in the U.S. designed to draw blood without the need for hands-on human help.
    Fierce Biotech · 11h ago↗ source
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Infectious Disease354
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 · 1d agoNeutral↗ source
  • B. Braun voluntarily recalls one lot of Excel Lactated Ringers IV solution over particulate contamination
    B. Braun Medical Inc announced a voluntary recall of a specific lot of its Excel Lactated Ringers Injection, a 1000 mL IV solution, after detecting particulate matter in the product. Laboratory an…
    fda recalls · 21h agoCRLNegative↗ 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 · 1d agoDealPositive↗ 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 · 1d 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 · 1d 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 · 1d agoLayoffsNegative↗ source
  • AstraZeneca’s Tagrisso plus Orpathys improves survival in MET-mutated lung cancer
    A new combination therapy using AstraZeneca’s Tagrisso together with Hutchmed’s Orpathys has shown a survival benefit for patients with a specific form of non‑small cell lung cancer. The study focu…
    BioPharma Dive · 2d agoPositive readoutPositive↗ source
  • Amylyx reports avexitide cuts severe hypoglycemia by 55% in bariatric surgery patients
    Amylyx Pharmaceuticals announced that its GLP-1 blocker avexitide achieved the primary endpoint in a late‑stage trial, reducing serious to severe hypoglycemic events by 55% compared with placebo in…
    BioPharma Dive · 2d 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 · 2d agoDealNeutral↗ 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 · 2d agoPositive↗ source
  • EyePoint shares tumble as Durayvu misses primary goal in wet AMD trial
    EyePoint, a Boston biotech, saw its market value drop by nearly $1 billion after its lead candidate Durayvu failed to demonstrate non-inferiority to aflibercept in a pivotal phase 3 trial for wet a…
    BioPharma Dive · 3d agoNegative readoutNegative↗ source
  • AstraZeneca halts Phase 3 lung cancer trial of bispecific antibody volrustomig after interim data miss survival goal
    AstraZeneca announced termination of the Phase 3 study of its experimental bispecific antibody volrustomig in non‑small cell lung cancer. An interim data review by trial monitors indicated the dru…
    BioPharma Dive · 3d agoNegative readoutNegative↗ 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 · 3d 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 · 3d 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 · 3d agoNegative readoutNegative↗ source
  • How AI-enabled Software as Medical Devices are Reshaping Regulatory Routes and Medicine
    As AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, s…
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • Slate Medicines to merge with Fulcrum Therapeutics after Fulcrum drops sickle-cell drug
    Slate Medicines announced it will combine with Fulcrum Therapeutics in a reverse merger, giving the struggling biotech a new corporate home. Fulcrum had been developing pociredir, a therapy design…
    BioPharma Dive · 3d agoDealNegative↗ source
  • Capricor shares jump as FDA signals openness to review updated Duchenne therapy
    Capricor Therapeutics saw its stock rise sharply after CEO Linda Marbán told analysts that the FDA is willing to look at an amended filing for its Duchenne muscular dystrophy cell therapy, deramioc…
    BioPharma Dive · 6d agoRegulatoryPositive↗ source
  • Zealand Pharma sells rights to rare blood cancer drug rusfertide for up to $100M
    Zealand Pharma entered a royalty purchase and sale agreement with Royalty Pharma, receiving $50 million upfront and the possibility of an additional $50 million after one year. In exchange, Zealan…
    BioSpace · 7d agoDealNeutral↗ source
  • Zealand Pharma sells its rights to Takeda's rusfertide for $100 million ahead of FDA decision
    Zealand Pharma has agreed to sell its economic interest in rusfertide, a peptide drug being developed by Takeda and Protagonist Therapeutics, for $100 million. The transaction comes as the FDA rev…
    Fierce Biotech · 7d agoDealNeutral↗ source
  • Silence Therapeutics' Phase 2 trial shows strong results for divesiran in polycythemia vera, shares jump 30%
    Silence Therapeutics reported that its nucleic‑acid drug divesiran achieved a 69% placebo‑adjusted response rate in a Phase 2 study of polycythemia vera patients. Safety was reported as clean, with…
    BioPharma Dive · 8d agoPositive readoutPositive↗ source
  • Hemab Therapeutics IPO raises $301.5M, stock triples and funds runway to 2029
    Hemab Therapeutics completed an upsized $301.5 million IPO in May, boosting total proceeds to $346.7 million. The offering helped the company’s share price climb from $18 at debut to $53.48 by mid‑…
    Fierce Biotech · 9d agoDealPositive↗ source
  • Zydus Sentynl signs up to $475M deal to license Mereo's phase-3 ready rare lung disease drug alvelestat in U.S.
    Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, announced a licensing agreement with Mereo BioPharma for the U.S. rights to alvelestat, a neutrophil elastase inhibitor that has completed…
    Fierce Biotech · 9d agoDealPositive↗ source