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90 stories matching this filter · ← front page

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  • FDA approves Emcitate for peripheral thyrotoxicosis in patients with MCT8 deficiency
    The U.S. Food and Drug Administration announced approval of Emcitate (tiratricol) tablets formulated for oral suspension to treat peripheral thyrotoxicosis in patients with MCT8 deficiency, also ca…
    fda press · 21d agoApprovalPositive↗ source
  • FDA grants accelerated approval for Etcamah combo therapy for advanced HR-positive, HER2-negative breast cancer
    The U.S. Food and Drug Administration announced accelerated approval of Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for adult patients with hormone-receptor-positive, HER2-negativ…
    fda press · 1mo agoApprovalPositive↗ source
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  • FDA releases draft guidance on evaluating drug behavior in patients with liver impairment
    The FDA has issued a draft guidance outlining how sponsors should design and analyze studies that assess the pharmacokinetics and pharmacodynamics of medicines in individuals with hepatic impairmen…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA considers two new executive posts and approves first-of-its-kind early drug and ketone‑glucose wearable
    The Health and Human Services department is reportedly evaluating the creation of two additional senior positions within the FDA, a step that could increase agency oversight. In recent approvals,…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA grants accelerated approval to Genglycos, first therapy for glycogen storage disease type Ia
    The U.S. Food and Drug Administration issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr), marking the first therapy for patients aged eight years and older with glycogen…
    fda press · 2mo agoApprovalPositive↗ source
  • BMS to build $2.3 B Houston plant as MHRA clears Lilly's weight-loss drug; IMDRF issues PCCP guidance
    Bristol Myers Squibb announced a plan to invest about $2.3 billion in a new manufacturing facility in Houston. The site is expected to expand the company’s production capacity for its pipeline and…
    raps · 2mo agoRegulatoryNeutral↗ source
  • FDA selects Dexcom as first participant in TEMPO digital health pilot
    The U.S. Food and Drug Administration announced that Dexcom, Inc. has been chosen as the inaugural manufacturer for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot focused on digit…
    fda press · 3mo agoRegulatoryPositive↗ 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