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87 stories matching this filter · ← front page

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  • J&J and Contineum's oral M1 inhibitor fails second mid-stage depression trial
    Contineum Therapeutics and Johnson & Johnson reported that their oral M1 receptor inhibitor, known as PIPE-307 or JNJ-5120, did not meet its primary endpoints in a Phase II study for major depressi…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Experts urge FDA to require credentials for psychedelic therapy providers
    At a recent public hearing, mental health experts called on the FDA to adopt safety measures as it pushes to speed up psychedelic therapy development. The experts specifically recommended that pro…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
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fda medwatch89
globenewswire health73
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Psychiatry & CNS1100
Ophthalmology840
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Pain650
Nephrology627
  • Definium Therapeutics reports positive Phase 3 results for oral LSD anxiety drug DT120
    Definium Therapeutics announced Monday that its experimental oral LSD formulation, DT120, achieved positive outcomes in a Phase 3 trial targeting an anxiety disorder. The trial, the company's thir…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Sword Health proposes acquisition of mental-health startup Headspace, linking two digital health unicorns
    Sword Health announced a proposal to acquire Headspace, a mental-health startup, according to a filing with Massachusetts state officials. The deal would combine two digital-health companies that…
    Endpoints · 1mo agoDealNeutral↗ source
  • Definium's oral LSD candidate passes first Phase 3 trial in generalized anxiety disorder
    Definium Therapeutics announced that its oral LSD candidate has successfully completed a Phase 3 trial in generalized anxiety disorder. The study met its primary endpoints, marking the first of tw…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Supernus and Indivior announce all-stock merger to create CNS-focused drugmaker
    Supernus Pharmaceuticals and Indivior Pharmaceuticals have signed an all‑stock merger agreement to combine their businesses. The new company will be dedicated to developing treatments for central…
    Endpoints · 2mo agoDealPositive↗ source
  • Draig Therapeutics raises $65 million Series B to push depression drug targeting synapse repair
    Draig Therapeutics announced it has closed a $65 million Series B financing round that was oversubscribed. The capital will be used to advance its neuropsychiatry pipeline, with the lead program f…
    Endpoints · 3mo agoDealPositive↗ source
  • Virtual mental-health firms accelerate AI chatbot development using therapy session data
    People are turning to artificial intelligence for daily tasks, companionship and emotional support, prompting virtual mental‑health providers to explore AI solutions. Companies that were previousl…
    Endpoints · 3mo agoNeutral↗ source
  • HMNC Brain Health raises $50M Series B to advance two depression drugs
    HMNC Brain Health announced it has closed a $50 million Series B financing round. The capital will be used to move two depression drug candidates into mid-stage clinical trials. The round was led…
    Endpoints · 4mo agoDealNeutral↗ 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
  • 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 · 5mo 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 · 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