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89 stories matching this filter · ← front page

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  • Centric Compounding recalls Glutathione, Myer’s Cocktail and Tri-Immune Boost injectables over elevated endotoxin levels
    Centric Compounding LLC announced a voluntary recall of six lots of its injectable products Glutathione 200 mg/mL, Myer’s Cocktail and Tri-Immune Boost. The recall was issued on September 9, 2026 a…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • B. Braun recalls three lots of 0.9% Sodium Chloride injection due to zinc oxide particles
    B. Braun Medical Inc announced a voluntary recall of three lots of its 0.9% Sodium Chloride Injection USP, 100 mL, packaged in a 150 mL PAB® container. The recall was triggered after testing ident…
    fda medwatch · 1mo agoCRLNegative
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Ophthalmology840
Endocrinology & Metabolism682
Pain650
Nephrology627
↗ source
  • FDA releases draft guidance on potency testing for immunotherapy products
    The FDA’s Center for Biologics Evaluation and Research (CBER) has issued a draft guidance document aimed at helping sponsors evaluate potency assays for active immunotherapy products (ACTIMPs). Th…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Fresenius Kabi recalls one lot of Morphine Sulfate Injection after labeling error mixes Dilaudid syringes
    Fresenius Kabi announced a voluntary recall of a single lot of its Morphine Sulfate Injection USP, Simplist 2 mg/1 mL product. The recall stems from a labeling mistake where the MicroVault contain…
    fda medwatch · 2mo agoCRLNegative↗ source
  • AVB-001 Cell Therapy Demonstrates Safety and Immune Activation in Platinum-Resistant Ovarian Cancer
    AVB-001, an encapsulated interleukin-2 cell therapy, was evaluated in patients with platinum-resistant high-grade serous ovarian carcinoma. The study reported that the treatment was well tolerated.…
    onclive · 5mo agoPositive readoutPositive↗ source
  • Triplet immunotherapy improves survival in HER2‑positive gastric cancer, suggesting broader immune activation
    New data from a study of HER2‑positive gastric cancer patients evaluated a triplet immunotherapy regimen. The analysis compared the combination against standard approaches and focused on overall su…
    onclive · 5mo agoPositive readoutPositive↗ 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 · 5mo agoApprovalPositive↗ source
  • 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 · 5mo agoApprovalPositive↗ 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 · 5mo 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 · 5mo 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 · 5mo agoApprovalPositive↗ 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 · 5mo agoPositive↗ 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 · 5mo agoNeutral↗ 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 · 5mo agoDealPositive↗ 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 · 5mo 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 · 5mo agoPositive readoutPositive↗ source
  • Experts discuss the evolving role of radiopharmaceuticals in advanced prostate cancer
    Dr. Pedro Barata and Dr. Johann de Bono wrapped up a series on metastatic castration-resistant prostate cancer by looking ahead to how radiopharmaceutical treatments may shape care. They highlight…
    onclive · 5mo agoPositive↗ source
  • Experts highlight growing complexity of personalized therapy choices for metastatic castration-resistant prostate cancer
    Dr. Johann De Bono and Dr. Pedro Barata discuss how treatment decisions for metastatic castration-resistant prostate cancer are becoming more intricate as new radiopharmaceuticals and targeted agen…
    onclive · 5mo agoNeutral↗ source
  • Experts outline emerging radiopharmaceutical approaches for metastatic castration-resistant prostate cancer
    Dr. Pedro Barata and Dr. Johann De Bono discuss the next steps for radiopharmaceutical therapies aimed at metastatic castration-resistant prostate cancer, highlighting how these agents could reshap…
    onclive · 5mo agoNeutral↗ source
  • Experts discuss sequencing and patient selection for radiopharmaceuticals in advanced prostate cancer
    Dr. Johann De Bono and Dr. Pedro Barata discuss how treatment sequencing is evolving for radiopharmaceuticals in metastatic castration-resistant prostate cancer. They highlight the need to match p…
    onclive · 5mo agoNeutral↗ source
  • Choosing the Right Radiopharmaceuticals for Advanced Prostate Cancer
    Dr. Pedro Barata and Dr. Johann De Bono discuss how patient selection and disease characteristics affect the use of radiopharmaceuticals in metastatic castration‑resistant prostate cancer (mCRPC).…
    onclive · 5mo agoNeutral↗ source
  • Experts review expanding role of radiopharmaceuticals in metastatic castration-resistant prostate cancer
    Dr. Pedro Barata and Dr. Johann De Bono open a discussion on the evolving role of radiopharmaceuticals in metastatic castration-resistant prostate cancer (mCRPC). They describe how these agents ar…
    onclive · 5mo agoNeutral↗ source
  • Experts discuss why anti-CCR8 antibody denikitug is being tested in phase 1 solid tumor trials
    Dr Bruno B. Bockorny, a gastrointestinal oncologist at Beth Israel Deaconess Medical Center and assistant professor at Harvard Medical School, explained the scientific basis for testing the anti‑CC…
    onclive · 5mo agoNeutral↗ source
  • Experts outline safety strategies for radiopharmaceutical treatment of advanced prostate cancer
    Dr. Johann De Bono and Dr. Pedro Barata presented a discussion focused on practical methods for monitoring and managing toxicities that arise from radiopharmaceutical therapies used in metastatic c…
    onclive · 5mo agoNeutral↗ source
  • Experts discuss combining radiopharmaceuticals with systemic therapies for advanced prostate cancer
    Dr. Pedro Barata and Dr. Johann de Bono presented a discussion on emerging combination strategies that pair radiopharmaceuticals with other systemic treatments for metastatic castration-resistant p…
    onclive · 5mo agoNeutral↗ source