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81 stories matching this filter · ← front page

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  • FDA signals openness to innovative approaches for psychedelic drug development
    FDA officials said the agency is open to novel, innovative approaches to the clinical development of psychedelic drugs, citing the worsening mental health crisis in the United States. The agency’s…
    raps · 2d agoRegulatoryNeutral↗ source
  • Experts suggest new safety framework to boost predictability of CNS toxicity assessments
    A recent paper outlines a safety framework intended to make central nervous system (CNS) toxicity predictions more reliable during drug development. The authors argue that new approach methodologi…
    raps · 26d agoNeutral↗ source
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  • FDA approves Orzeyful, first drug to treat all symptoms of narcolepsy type 1
    The U.S. Food and Drug Administration announced on August 5, 2026 that it has approved Orzeyful (oveporexton) tablets for adults with narcolepsy type 1. Orzeyful is the first therapy cleared to tr…
    fda press · 1mo agoApprovalPositive↗ source
  • Australia's TGA opens consultation to revamp rules for digital mental health tools
    The Therapeutic Goods Administration (TGA) has launched a public consultation aimed at updating the regulatory framework that governs digital mental health tools in Australia. The move seeks to cla…
    raps · 1mo agoRegulatoryNeutral↗ 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 · 4mo 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 · 4mo 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 · 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
  • 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 · 4mo agoPositive↗ 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
  • 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
  • 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
  • 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
  • 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
  • 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo agoNeutral↗ source
  • Oncologist Charles Blanke reflects on cancer research journey and push for medical aid in dying
    The latest episode of the "How This Is Building Me" podcast features D. Ross Camidge, MD, PhD, speaking with Charles D. Blanke, MD, a professor at Oregon Health & Science University. The conversati…
    onclive · 4mo agoPositive↗ source