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86 stories matching this filter · ← front page

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  • Definium's LSD pill shows positive results in late-stage anxiety trial
    Definium Therapeutics reported that its pharmaceutical-grade LSD formulation, DT120, achieved positive outcomes in a late-stage study targeting generalized anxiety disorder. The trial used a 56-po…
    BioPharma Dive · 26d agoPositive readoutPositive↗ source
  • FDA approves Takeda’s orexin-2 drug Orzeyful for narcolepsy type 1
    The U.S. Food and Drug Administration has approved Takeda Pharmaceutical's new sleep medication, Orzeyful, marking the first product in the emerging orexin‑2 drug class. Orzeyful works by amplifyi…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
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fda recalls67
fda medwatch60
fda press38
858
Ophthalmology491
Pain468
Endocrinology & Metabolism465
Infectious Disease437
  • Supernus and Individor to merge, creating $2 billion brain-drug company
    Supernus and Individor announced a merger that will combine their portfolios of neurological medicines. The two firms together generated about $2 billion in revenue in 2025 from roughly a dozen CN…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • MapLight shares plunge 66% after mid-stage schizophrenia trial shows modest benefit but raises competitive concerns
    MapLight Therapeutics announced results from its mid‑stage trial of an experimental schizophrenia drug. The study enrolled adults experiencing an acute exacerbation of psychotic symptoms. The twic…
    BioPharma Dive · 1mo agoPositive readoutNegative↗ source
  • Biotech sector eyes key clinical trial readouts in H2 2026 across cancer, Alzheimer’s and autoimmune diseases
    The first half of 2026 saw a surge in biotech activity, with record‑high deal flow, several large IPOs and a regulatory environment that appears to be stabilising after a period of uncertainty. An…
    BioPharma Dive · 2mo agoNeutral↗ source
  • Rapport Therapeutics says it is ready to launch its seizure drug independently
    In a recent interview, CEO Abe Ceesay explained that Rapport Therapeutics has assembled an investor syndicate and feels fully prepared to bring its seizure drug to market on its own. Founded in 20…
    BioPharma Dive · 2mo agoDealPositive↗ 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
  • 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 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoNeutral↗ source