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3,091 stories matching this filter · ← front page

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  • MetALD emerges as a growing U.S. liver crisis linked to obesity, diabetes and heavy drinking, hitting young adults and women
    U.S. doctors are naming a new liver condition, MetALD, that combines metabolic dysfunction with alcohol related damage. The syndrome reflects the overlap of obesity, diabetes and heavy drinking tha…
    STAT · 4mo agoNegative↗ source
  • FDA approves brexu-cel for adult relapsed/refractory mantle cell lymphoma
    The U.S. Food and Drug Administration has granted approval for brexu-cel as a treatment option for adult patients with relapsed or refractory mantle cell lymphoma. Dr. Luhua (Michael) Wang discuss…
    onclive · 4mo agoApprovalPositive↗ source
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  • iECURE’s early gene-therapy success in a baby fails to replicate in larger trial
    Early last year iECURE reported that its experimental gene therapy appeared to cure an infant suffering from a severe genetic disorder. The company has now released data from a follow-up study tha…
    Endpoints · 4mo agoNegative readoutNegative↗ source
  • FDA grants accelerated approval to sonrotoclax for relapsed/refractory mantle cell lymphoma
    The U.S. Food and Drug Administration has granted accelerated approval to sonrotoclax (brand name Beqalzi) for adult patients with relapsed or refractory mantle cell lymphoma who have received at l…
    onclive · 4mo agoApprovalPositive↗ source
  • Pirtobrutinib Extends Progression-Free Survival to 14 Months in BTK-Inhibitor-Pretreated CLL Patients
    The phase 3 CLL-321 trial enrolled patients whose disease had progressed after prior covalent BTK inhibitor therapy. Participants were randomly assigned to receive pirtobrutinib or the investigator…
    onclive · 4mo agoPositive readoutPositive↗ source
  • FDA expands pirtobrutinib use to second-line CLL after covalent BTKi failure, broadening treatment options
    The BRUIN CLL-321 phase 3 trial provided the data that led the FDA to approve pirtobrutinib for patients whose chronic lymphocytic leukemia has progressed after a covalent BTK inhibitor. This marks…
    onclive · 4mo agoApprovalPositive↗ source
  • Oral SERDs show promise in hormone-receptor positive breast cancer, offering alternative to injections
    Oral selective estrogen receptor degraders (SERDs) are being positioned as a new approach for metastatic hormone-receptor positive breast cancer because they can break down the estrogen receptor an…
    onclive · 3mo agoPositive readoutPositive↗ source
  • Retifanlimab plus chemo improves progression-free survival in first-line SCAC trial
    Topline results from the PODIUM-303 study show that adding the PD-1 inhibitor retifanlimab to carboplatin and paclitaxel improves outcomes for patients with squamous cell carcinoma of the anal cana…
    onclive · 3mo agoPositive readoutPositive↗ source
  • MD Anderson expert highlights impact of WHO’s updated AML diagnostic criteria on patient care
    Dr Sanam Loghavi, an associate professor and medical director at MD Anderson Cancer Center, discussed the recently revised WHO diagnostic criteria for acute myeloid leukemia. She emphasized that a…
    onclive · 3mo agoPositive↗ source
  • Takeda plans to cut 4,500 jobs, about 9% of workforce, under new CEO's restructuring plan
    Takeda announced it will eliminate roughly 9% of its global workforce, affecting about 4,500 positions, over the coming fiscal year. The cuts are part of a restructuring effort that began under th…
    Endpoints · 4mo agoLayoffsNegative↗ source
  • Tirabrutinib and CAR T-cell therapy show promise for relapsed/refractory primary CNS lymphoma
    Experts highlighted emerging data on tirabrutinib and CAR T-cell therapy as potential new options for patients with relapsed or refractory primary central nervous system lymphoma. CAR T-cell thera…
    onclive · 4mo agoRegulatoryPositive↗ source
  • Valneva to cut up to 15% of workforce as travel slowdown lowers vaccine demand
    Valneva, a French vaccine developer, announced it will lay off between 10% and 15% of its employees. The cuts are linked to a decline in demand for travel vaccines, which the company says is drive…
    Endpoints · 4mo agoLayoffsNegative↗ source
  • Trump administration seeks new FDA commissioner to restore trust, prioritize food policy and accelerate drug approvals
    The Trump administration is moving quickly to name a successor to FDA commissioner Marty Makary, who resigned. Officials say the search will take several weeks and they are looking for a leader wh…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Experts discuss combination and sequencing approaches for radiopharmaceuticals in advanced prostate cancer
    Dr. Pedro Barata and Dr. Johann De Bono review the current questions surrounding how best to combine and sequence radiopharmaceutical therapies for patients with metastatic castration‑resistant pro…
    onclive · 4mo agoNeutral↗ source
  • U.S. overdose deaths drop 14% in 2025, marking third consecutive yearly decline
    Preliminary CDC data show about 70,000 overdose deaths in 2025, roughly 14% fewer than in 2024 and similar to 2019 levels before the pandemic. The decline was observed across major drug categories…
    STAT · 4mo agoPositive↗ source
  • Abeona shifts from eye gene therapy to solid tumor T‑cell programs as AstraZeneca’s rare disease drug clears Phase 3
    Abeona Therapeutics announced it is ending its eye‑focused gene‑therapy projects and will redirect resources toward developing T‑cell based treatments for solid tumors. The company says the pivot…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Gene therapy viral vectors implicated in a child’s tumor, raising safety concerns
    A recent STAT+ report highlights a case where viral vectors used in gene therapy were found to be associated with a tumor in a young boy. The article notes that investigators have identified a poss…
    STAT · 4mo agoNegative↗ source
  • UCSF receives $100 million gift to fund capital projects, cancer research and hospital modernization
    Longtime supporters Kathy Chiao and Kenneth Hao have pledged $100 million to the University of California, San Francisco. The commitment is intended to address the university’s most urgent capital…
    onclive · 4mo agoDealPositive↗ source
  • Tessera Therapeutics reports infusion gene edit corrects 85% of blood cells in sickle cell study
    Tessera Therapeutics announced new data from its in-vivo gene editing program targeting sickle cell disease. The experimental therapy is given as a simple infusion, avoiding the complex cell engin…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Biomarker testing guides endometrial cancer treatment and highlights gaps in second-line options after immunotherapy
    The discussion highlighted that performing biomarker testing at diagnosis is now standard for endometrial cancer, helping decide between targeted therapies and immunotherapy. The experts described…
    onclive · 4mo agoNeutral↗ source
  • Merck KGaA sees client stockpiling of lab equipment amid Iran war, lifts guidance
    Merck KGaA's CFO Helene von Roeder said the company is observing a rise in demand for its laboratory equipment as customers increase inventories in response to the ongoing war in Iran. The heighte…
    Endpoints · 4mo agoPositive↗ source
  • Safety-boosting drug may weaken gene therapy efficacy in Dravet syndrome trial
    Encoded Therapeutics studied a drug meant to improve the safety of gene therapy in children with Dravet syndrome, a severe genetic epilepsy. In the trial of 21 participants, most received steroids…
    STAT · 4mo agoNegative readoutNegative↗ source
  • Doctors link infant's brain tumor to gene therapy virus in rare case
    Doctors treated 13-month-old Adam with an experimental gene therapy after his stem cell transplant failed, and the boy subsequently reached developmental milestones such as learning sign language a…
    STAT · 4mo agoNeutral↗ source
  • Alpha-emitting radiopharmaceuticals gain attention in metastatic castration-resistant prostate cancer
    Dr. Johann De Bono and Dr. Pedro Barata reviewed the current landscape of alpha-emitting radiopharmaceuticals for patients with metastatic castration-resistant prostate cancer (mCRPC). They highli…
    onclive · 4mo agoPositive readoutPositive↗ source
  • FDA Commissioner Marty Makary Ousted After Trump-Backed Action
    The piece reports that Marty Makary, who had been serving as FDA commissioner, is no longer in the role. His removal came after headlines emerged that President Donald Trump had signed a measure…
    Endpoints · 4mo agoRegulatoryNegative↗ source