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  • AstraZeneca reports Phase 3 trial shows Imfinzi-Padcev combo improves survival in bladder cancer
    AstraZeneca announced that its Phase 3 study of the immunotherapy Imfinzi combined with the antibody‑drug conjugate Padcev, developed with Pfizer and Astellas, extended overall survival for patient…
    Endpoints · 5mo agoPositive readoutPositive↗ source
  • BeOne secures FDA approval for lymphoma therapy
    BeOne received FDA approval for its lymphoma therapy, a notable achievement in a crowded therapeutic area. The agency’s review concluded that the treatment meets safety and efficacy standards, pla…
    STAT · 5mo agoApprovalPositive↗ source
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  • Regenxbio reports successful Duchenne gene therapy trial, clearing path to FDA filing
    Regenxbio announced that its experimental gene therapy for Duchenne muscular dystrophy met its primary endpoints in a recent clinical trial, producing sufficient levels of a truncated muscle protei…
    STAT · 5mo agoPositive readoutPositive↗ source
  • Create Medicines secures $122M Series B to advance in vivo CAR-T therapies
    Create Medicines, a Cambridge biotech, announced a $122 million Series B financing to expand its in vivo CAR-T cell therapy platform targeting cancer and autoimmune diseases. The round was co-led…
    BioPharma Dive · 5mo agoDealPositive↗ source
  • Phase III trial shows tebentafusp doubles five-year survival in untreated metastatic uveal melanoma
    A Phase III study of tebentafusp in patients with previously untreated metastatic uveal melanoma reported that five-year overall survival was roughly twice that of the control group. The trial als…
    onclive · 5mo agoPositive readoutPositive↗ source
  • Biogen advances tau-targeting Alzheimer drug to Phase 3 despite mixed Phase 2 data
    Biogen reported results from a Phase 2 trial of its tau-targeting Alzheimer’s candidate diranersen (BIIB080). The study measured tau levels in cerebrospinal fluid and brain tissue of patients with…
    STAT · 5mo agoPositive readoutPositive↗ source
  • BeOne Medicines receives accelerated FDA approval for sonrotoclax in mantle cell lymphoma
    BeOne Medicines announced that the U.S. Food and Drug Administration granted accelerated approval to its BCL2 inhibitor sonrotoclax for treatment of mantle cell lymphoma. The approval is based on…
    Endpoints · 5mo agoApprovalPositive↗ source
  • FDA commissioner Marty Makary exits, acting head Kyle Diamantas named as podcast discusses impact and Senate health race
    The Readout Loud podcast episode focused on health politics, featuring a discussion of FDA commissioner Marty Makary's departure. Hosts examined why Makary is leaving, which of his policies might…
    STAT · 5mo agoRegulatoryNeutral↗ source
  • Rintatolimod added to pembrolizumab and cisplatin yields 50% response rate in recurrent ovarian cancer
    A clinical study evaluated the combination of rintatolimod, pembrolizumab and cisplatin in patients with recurrent ovarian cancer. The regimen produced an objective response rate of 50%, indicatin…
    onclive · 5mo agoPositive readoutPositive↗ source
  • Stage IV Breast Cancer Cases Rise Over Past Decade, Dana-Farber Study Shows
    A recent analysis by Dana-Farber Cancer Institute examined breast cancer diagnoses over the past ten years. The researchers found that the number of patients diagnosed with stage IV disease has ri…
    onclive · 5mo agoNeutral↗ source
  • Experts anticipate Daraxonrasib and new GI cancer therapies at ASCO 2026
    Ahead of the 2026 ASCO Annual Meeting, leading oncologists and researchers focusing on gastrointestinal cancers highlighted the topics they expect to dominate the conference. Central among the buz…
    onclive · 5mo agoNeutral↗ 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
  • Zenidatamab regimens show survival benefit in HER2-positive gastric cancer, but PD-L1 test variability raises treatment questions
    The HERIZON‑GEA‑01 study reports that zenidatamab‑based treatment schedules lead to a notable improvement in overall survival for patients with HER2‑positive gastric cancer. These efficacy finding…
    onclive · 5mo agoPositive readoutPositive↗ source
  • CREATE Medicines raises $122 million to advance CAR-T candidates into human trials
    CREATE Medicines, formerly Myeloid Therapeutics, announced a $122 million financing round. The funding came from Newpath Partners, ARCH Venture Partners, Hatteras Venture Partners and other invest…
    STAT · 5mo agoDealPositive↗ source
  • Dr. Jones reports GLP-1 agonists may outperform aspirin in colorectal cancer prevention and tolerability
    Dr. Colton Jones presented findings from a retrospective analysis that compared GLP-1 receptor agonists with aspirin for primary prevention of colorectal cancer. The analysis indicated that patien…
    onclive · 5mo agoPositive readoutPositive↗ source
  • Understanding MET Alterations in Non‑Small Cell Lung Cancer and Emerging Targeted Treatment Options
    The article outlines the primary MET alterations observed in non‑small cell lung cancer, focusing on gene amplification and exon 14 skipping mutations. It explains that these MET changes frequentl…
    onclive · 5mo agoNeutral↗ source
  • REVELUTION-2 trial assesses cardiovascular safety of relugolix plus abiraterone in high‑risk prostate cancer
    The REVELUTION-2 study is focused on measuring the heart‑related risks associated with a hormone‑therapy regimen that combines relugolix and abiraterone acetate in patients with high‑risk prostate…
    onclive · 5mo agoNeutral↗ source
  • TROP2 scoring and MTAP loss emerge as key biomarkers for NSCLC treatment decisions
    Researchers are highlighting two molecular features-TROP2 expression and loss of the MTAP enzyme-as potential guides for therapy in non‑small cell lung cancer. Quantitative scoring of TROP2 by pat…
    onclive · 5mo agoNeutral↗ source
  • Key AUA 2026 abstracts to watch: immunotherapy for NMIBC and radioligand therapy for mHSPC
    The American Urological Association 2026 meeting will feature several highly anticipated abstracts. Experts say immunotherapy for non‑muscle‑invasive bladder cancer is a major focus, reflecting gr…
    onclive · 5mo agoNeutral↗ source
  • Case Introduction Highlights ctDNA as Emerging Risk Factor
    The article presents a case introduction that focuses on circulating tumor DNA (ctDNA) as a potential emerging risk factor. It outlines the relevance of ctDNA in assessing disease risk, emphasizin…
    onclive · 5mo agoNeutral↗ source
  • MRI Features That Suggest Diffuse Midline Glioma Highlighted in Expert Discussion
    In a recent educational segment, Dr. Chong introduced the clinical scenario where patients with suspected brain tumors are first evaluated with imaging before tissue sampling. He then asked Dr. Sh…
    onclive · 5mo agoNeutral↗ 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