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  • Article on clinical implementation and surveillance provides no details
    The source article titled "Clinical Implementation and Surveillance Strategies" contains no summary or body text. No specific information about implementation methods, surveillance approaches, or…
    onclive · 3mo agoNeutral↗ source
  • FDA approves oral decitabine/cedazuridine plus venetoclax for older AML patients unable to tolerate intensive chemo
    The FDA has approved the oral combination of decitabine/cedazuridine (Inqovi) with venetoclax (Venclexta) for adults with newly diagnosed acute myeloid leukemia who are at least 75 years old or hav…
    onclive · 3mo agoApprovalPositive↗ source
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  • FDA approves all-oral decitabine/cedazuridine plus venetoclax for older or unfit AML patients
    The FDA has granted approval for the combination of decitabine and cedazuridine (Inqovi) with venetoclax (Venclexta) to treat newly diagnosed acute myeloid leukemia in adults who are at least 75 ye…
    onclive · 3mo agoApprovalPositive↗ 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 · 3mo agoApprovalPositive↗ source
  • 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 · 3mo 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 · 3mo agoApprovalPositive↗ source
  • FDA leadership gap deepens uncertainty for biotech as acting officials take charge
    Marty Makary's resignation as FDA commissioner has left the agency without a permanent head. Kyle Diamantas is serving as the temporary leader, while three senior drug-review positions are filled b…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • Lilly data show lower-dose GLP-1 injections and oral pill help sustain weight loss
    Eli Lilly presented new research on how patients who have lost weight with GLP‑1 medicines can maintain that loss over time. The studies followed people who had achieved significant reductions usin…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Assertio rejects Garda bid, accepts Zydus offer valuing company at $23.50 per share
    Assertio Holdings announced it has terminated its pending acquisition by Garda Therapeutics after the board approved a higher offer from another suitor. The new proposal from Zydus Worldwide value…
    BioPharma Dive · 3mo agoDealNeutral↗ 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoLayoffsNegative↗ 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 · 3mo agoNeutral↗ 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 · 3mo agoPositive readoutPositive↗ 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 · 3mo 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 · 3mo 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 · 3mo agoNeutral↗ source
  • Podcast Highlights Community Oncology’s Growing Role in U.S. Cancer Care
    A new sponsored podcast episode explores how community oncology clinics are becoming a vital part of the U.S. cancer‑care landscape. The program, released in May 2026, discusses why these local cen…
    BioPharma Dive · 3mo agoPositive↗ 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 · 3mo agoPositive↗ 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 · 3mo agoPositive readoutPositive↗ source