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1,896 stories matching this filter · ← front page

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  • FDA holds Type A meeting with Atara after CRL issued for tabelecleucel in EBV-positive PTLD
    The FDA and Atara Biotherapeutics met in a Type A meeting to discuss the complete response letter (CRL) that the agency issued for the biologics license application of tabelecleucel, a therapy for…
    onclive · 6mo agoCRLNegative↗ source
  • Entrada's Duchenne drug shows disappointing early data, shares tumble
    Entrada disclosed initial results from a low‑dose version of its exon‑44 skipping therapy for Duchenne muscular dystrophy. The data, collected from six patients, failed to meet the company’s expect…
    Endpoints · 6mo agoNegative readoutNegative↗ source
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  • Amgen invests $300 million in Puerto Rico biologics plant as Novartis plans to close German oral drug factory
    Amgen announced an additional $300 million investment in Puerto Rico to expand its biologics manufacturing capacity in Juncos, building on earlier commitments. The funding will be used to upgrade…
    Endpoints · 6mo agoDealNeutral↗ source
  • Atara and Pierre Fabre's T-cell therapy gets new chance for FDA approval after twice rejected
    Atara Biotherapeutics and Pierre Fabre Pharmaceuticals have received notice from the U.S. FDA that it will reconsider a previously rejected T-cell therapy. The therapy, which had been turned down…
    Endpoints · 6mo agoRegulatoryPositive↗ source
  • Clinicians map next-line EGFR lung cancer treatments using NGS, radiation, chemo, amivantamab and ADCs
    Clinicians treating non‑small cell lung cancer with EGFR mutations must adapt when tumors become resistant to first‑line therapies. The latest guidance highlights the use of next‑generation sequenc…
    onclive · 6mo agoNeutral↗ source
  • Experts discuss real-world evidence and research gaps in metastatic castration-sensitive prostate cancer
    Industry and academic experts gathered to examine how real-world evidence can be used to compare treatments for metastatic castration-sensitive prostate cancer. They highlighted the strengths and l…
    onclive · 6mo agoNeutral↗ source
  • Zanidatamab shows strong single-agent activity in HER2-positive gastric and biliary cancers
    Zanidatamab, a dual HER2-binding antibody, demonstrated notable efficacy as a single agent in studies of gastric and biliary tract cancers. The activity was described as striking, suggesting that…
    onclive · 6mo agoPositive readoutPositive↗ source
  • Astellas reports promising early results for stem cell eye therapy ASP7317 in age-related disease
    Astellas announced data from an early-stage trial of ASP7317, a stem cell-derived therapy aimed at an age-related eye condition. The study showed encouraging signs of efficacy and safety in most p…
    Endpoints · 6mo agoPositive readoutPositive↗ source
  • Experts preview promising triple-negative breast cancer studies for ASCO 2026
    At the 2026 ASCO Annual Meeting, leading breast cancer specialists highlighted the triple-negative breast cancer (TNBC) abstracts they consider most likely to influence clinical practice. The disc…
    onclive · 6mo agoNeutral↗ source
  • Lung cancer abstracts set to shape discussions at ASCO 2026
    OncLive has compiled a preview of lung‑cancer presentations that leading oncologists expect to influence clinical talks at the 2026 ASCO Annual Meeting in Chicago. The preview highlights insights f…
    onclive · 6mo agoNeutral↗ source
  • Experts discuss PD-L1 testing for HER2-positive metastatic gastric cancer as new trial data shifts immunotherapy timing
    The HERIZON-GEA-01 trial outlines its design and geographic enrollment while focusing on PD-L1 testing in HER2-positive metastatic gastric cancer. Clinicians and researchers are debating the role…
    onclive · 6mo agoNeutral↗ source
  • STK11 and MTAP loss reshape NSCLC prognosis and immunotherapy response, prompting new dual-checkpoint and PRMT5 inhibitor trials
    Recent analyses highlight that loss of the STK11 gene and co‑deletion of MTAP are common in non‑small cell lung cancer and are linked to poorer overall prognosis. These genetic alterations also ap…
    onclive · 6mo agoNeutral↗ source
  • Health insurers grapple with profit cuts after a costly 2025, outlook for 2026 remains uncertain
    In 2025, a wave of health insurers reduced or withdrew their profit forecasts after being hit by rising medical expenses. The cost pressures stemmed from higher drug prices, increased utilization…
    Endpoints · 6mo agoNegative↗ source
  • Expert discusses uncertainties in melanoma adjuvant therapy sequencing
    Dr. Mario Sznol, a professor of clinical medical oncology at the University of Miami, highlighted the difficulty of deciding whether to give adjuvant treatment to melanoma patients given the curren…
    onclive · 6mo agoNeutral↗ source
  • Women with bladder cancer often experience diagnostic delays as symptoms are mistaken for urinary infections
    Women with bladder cancer are frequently diagnosed later because their early signs are often confused with common urinary tract infections. Doctors say this confusion leads many patients to receiv…
    onclive · 6mo agoNegative↗ source
  • Amazon Pharmacy adds Ozempic pill to its same-day prescription kiosks
    Amazon Pharmacy announced that its same-day prescription kiosks will now dispense the Ozempic tablet, expanding the range of drugs available through the vending-style machines. The kiosks, which h…
    Endpoints · 6mo agoNeutral↗ source
  • Study Finds Screening Gap for HTLV-1 Linked Leukemia in US Caribbean-Born Communities
    Researchers at Sylvester Comprehensive Cancer Center have highlighted a gap in screening for adult T‑cell leukemia/lymphoma (ATLL) that could be addressed by preventing mother‑to‑child transmission…
    onclive · 6mo agoPositive↗ source
  • Experts discuss strengths and limits of real-world studies for prostate cancer drug comparisons
    Experts highlighted that observational and propensity-matched analyses are increasingly used to compare treatments for metastatic castration-sensitive prostate cancer. They noted that such real-wo…
    onclive · 6mo agoNeutral↗ source
  • Pennsylvania files lawsuit against Character.AI for presenting chatbot as licensed physician
    The Commonwealth of Pennsylvania has filed a lawsuit against Character.AI, a startup that offers users the ability to converse with AI-generated personas. The suit alleges that the company illegall…
    Endpoints · 6mo agoRegulatoryNegative↗ source
  • AAAS elects oncology leaders Guise and Watowich, highlight mentorship for early-career researchers
    Theresa A. Guise, MD, FASBMR, and Stephanie S. Watowich, PhD, have been elected as fellows of the American Association for the Advancement of Science (AAAS). The fellowship recognizes scientists wh…
    onclive · 6mo agoPositive↗ source
  • Oncology fellows urged to nurture curiosity throughout training
    Megan Dupuis, an early-career oncology faculty member at Vanderbilt University Medical Center, shares a story from a rural clinic visit where a patient’s personal background – a one-room schoolhous…
    onclive · 6mo agoPositive↗ source
  • FDA approves nivolumab plus AVD for untreated advanced-stage Hodgkin lymphoma
    Dr. Alex Herrera, a professor and chief of lymphoma at City of Hope, highlighted the recent FDA clearance of the combination of nivolumab with the chemotherapy regimen AVD for patients with newly d…
    onclive · 6mo agoApprovalPositive↗ source
  • GSK signs $1 billion siRNA partnership with China's SiranBio to target obesity
    GSK is expanding its cardiometabolic portfolio by entering a new collaboration with Chinese biotech SiranBio. The agreement is valued at $1 billion in biobucks and focuses on developing siRNA ther…
    Endpoints · 6mo agoDealPositive↗ source
  • Neoadjuvant T-DXd then THP cuts residual cancer burden vs standard chemo in high-risk HER2-positive breast cancer
    The DESTINY‑Breast11 trial compared three neoadjuvant approaches for patients with high‑risk HER2‑positive early‑stage breast cancer: T‑DxD followed by paclitaxel, trastuzumab and pertuzumab (THP),…
    onclive · 6mo agoPositive readoutPositive↗ source
  • Eli Lilly to invest $4.5 billion in new manufacturing facilities across Indiana
    Eli Lilly announced a $4.5 billion allocation for new manufacturing projects in Indiana. The company said the funds will be used to build and upgrade production sites across the state, expanding it…
    Endpoints · 6mo agoPositive↗ source