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2,731 stories matching this filter · ← front page

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  • FDA policy lets some flavored vapes stay on shelves without full approval, raising expert concerns
    The Food and Drug Administration announced a new guidance that allows certain flavored e-cigarettes and nicotine pouches to remain on the market even though they have not received full authorizatio…
    STAT · 4mo agoRegulatoryNegative↗ source
  • INBRX-106 plus pembrolizumab shows higher response rate than pembrolizumab alone in first-line PD-L1-positive head-and-neck cancer
    The HexAgon-HN trial evaluated the OX40 agonist INBRX-106 combined with pembrolizumab in patients with treatment-naive, PD-L1‑positive metastatic or unresectable head‑and‑neck squamous cell carcino…
    onclive · 4mo agoPositive readoutPositive↗ source
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  • Daiichi Sankyo targets $15 billion in oncology sales by 2030 as it expands ADC franchise
    Daiichi Sankyo released a new five‑year business plan that sets a goal of nearly $15 billion in oncology revenue by 2030. The target is part of a broader ambition to push total company sales past 3…
    Endpoints · 4mo agoNeutral↗ source
  • Inhibrx reports combo of Keytruda and INBRX-106 reduces tumors more than Keytruda alone in metastatic head cancer
    San Diego biotech Inhibrx says its experimental drug INBRX-106, when added to Merck's immunotherapy Keytruda, led to a higher rate of tumor shrinkage than Keytruda by itself. The observation comes…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Astellas therapy brings new hope to rare disease patients amid broader biotech challenges
    A new Astellas treatment is being highlighted as a source of optimism for a community affected by a rare disease, after a period of setbacks in the program. The article also notes a revived gene t…
    STAT · 4mo agoPositive↗ source
  • Braveheart Bio's Hengrui-licensed cardiac therapy shows positive mid-stage trial results
    Braveheart Bio announced that its heart muscle therapy, licensed from Jiangsu Hengrui Pharmaceuticals, has achieved a positive outcome in a Phase 2 trial. The mid-stage study met its primary endpo…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Medicare uptake of newly approved Alzheimer’s drugs Leqembi and Kisunla falls short of expectations
    Medicare is seeing much lower use of the two Alzheimer’s treatments that received FDA approval earlier this year. The drugs, Leqembi and Kisunla, were expected to generate notable spending for Med…
    STAT · 4mo agoRegulatoryNegative↗ source
  • ctDNA testing shows promise for renal cell carcinoma and germ cell tumors despite current limitations
    Experts discussed how circulating tumor DNA (ctDNA) monitoring, long used in bladder cancer, is being explored for renal cell carcinoma (RCC) and germ cell tumors. In RCC, low tumor shedding has l…
    onclive · 4mo agoNeutral↗ source
  • ctDNA monitoring guides immunotherapy decisions in metastatic urothelial cancer
    Experts discussed how circulating tumor DNA (ctDNA) testing is being used to follow patients with metastatic urothelial carcinoma and to help shape immunotherapy choices. They noted that a rapid d…
    onclive · 4mo agoPositive↗ source
  • European regulators approve Fractyl Health's first GLP-1 gene therapy clinical trial
    European regulators have given the green light for Fractyl Health, a biotech near Boston, to begin its first human study of a GLP-1 gene therapy. The therapy aims to provide a one-time treatment t…
    Endpoints · 4mo agoRegulatoryPositive↗ source
  • Experts call for licensing framework as Utah pauses AI chatbot prescription program
    Alon Bergman, an assistant professor of medical ethics at the University of Pennsylvania, argues that AI-driven medical tools need a licensing system. He points to Utah’s recent pilot with the AI c…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Medicare cuts projected spending on new Alzheimer’s drugs as uptake remains low
    Medicare is spending far less on the recently approved Alzheimer’s treatments Leqembi and Kisunla than officials had anticipated. The Centers for Medicare and Medicaid Services said the agency does…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Optum Rx Announces Transparent Pharmacy Model Set to Launch in 2027
    Optum Rx, a unit of UnitedHealth Group, introduced a new pharmacy benefit model that promises clear fee structures for its customers. The model is designed to give members visibility into the full…
    Endpoints · 4mo agoPositive↗ source
  • Novo Nordisk secures biotech partner for Parkinson's cell therapy as GSK signs hepatitis B drug deal in China
    Novo Nordisk has found a biotech partner to advance its early‑stage Parkinson's disease cell therapy, giving the program a new development home. GSK disclosed a commercial agreement to sell its he…
    Endpoints · 4mo agoDealNeutral↗ source
  • Experts highlight growing role of treatment intensification for metastatic castration-sensitive prostate cancer
    During an OncLive Peer Exchange, prostate-cancer specialists examined how treatment intensification is reshaping management of metastatic castration-sensitive prostate cancer. They noted that andr…
    onclive · 4mo agoNeutral↗ source
  • Experts discuss when to start therapy for pediatric low‑grade glioma, weighing chemo, MEK inhibitors and family factors
    In a recent discussion, pediatric neuro‑oncologists examined how to decide when to begin treatment for low‑grade glioma in children. They highlighted the need to balance chemotherapy and MEK inhibi…
    onclive · 4mo agoNeutral↗ source
  • Dr Randall explains rationale for CSF-1R inhibitor pimicotinib in tenosynovial giant cell tumor trial
    Dr Randall, a professor at UC Davis Comprehensive Cancer Center, discussed the clinical reasoning behind testing the selective CSF-1R inhibitor pimicotinib (ABSK021) for tenosynovial giant cell tum…
    onclive · 4mo agoNeutral↗ source
  • Experts discuss how real-world patient factors shape first-line renal cell carcinoma treatment choices
    Dr. Elizabeth Plimack and Dr. Yasser Ged appeared in a recent segment to talk about first-line treatment selection for renal cell carcinoma. They explained that beyond clinical trial results, real…
    onclive · 4mo agoNeutral↗ source
  • Clinicians balance symptoms, MRI changes and family goals when deciding treatment for pediatric low-grade glioma, beyond size criteria
    In a recent discussion, pediatric neuro‑oncology experts examined how they apply the RAPNO criteria to assess low‑grade gliomas in children. They highlighted that treatment decisions often go beyon…
    onclive · 4mo agoNeutral↗ source
  • Experts discuss practical treatment selection for renal cell carcinoma across risk groups
    A recent educational segment featured Dr. Elizabeth Plimack together with Dr. Sundhar Ramalingam and Dr. Yasser Ged discussing treatment choices for renal cell carcinoma. The conversation centered…
    onclive · 4mo agoNeutral↗ source
  • MimiVax and Roswell Park start Phase 2 trial of SurVaxM with temozolomide for metastatic neuroendocrine tumors
    MimiVax Inc. and Roswell Park Comprehensive Cancer Center announced the launch of a randomized Phase 2 study evaluating SurVaxM in combination with temozolomide for patients with progressing metast…
    onclive · 4mo agoCRLNeutral↗ source
  • Providers and insurers vie to influence upcoming No Surprises Act arbitration rule
    The federal government is preparing to release a final rule that will reshape the arbitration process under the No Surprises Act. Health care providers and insurers are both scrambling to have thei…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Real-World Data Highlight Survival Benefit of Rituximab Maintenance After Frontline BR in MCL
    Rituximab following first-line bendamustine demonstrated significant OS and EFS real-world benefits in mantle cell lymphoma.
    onclive · 4mo agoNeutral↗ source
  • President Trump says government may consider approving certain forms of kratom-derived 7-OH
    President Trump suggested the federal government could move to approve some forms of 7-OH, an opioid derived from the kratom plant. 7-OH, short for 7-hydroxymitragynine, occurs naturally in kratom…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • FDA commissioner Marty Makary faces possible dismissal amid political pressure, while new insights link menstrual cycles to mental health
    Theresa Gaffney’s Morning Rounds newsletter highlighted a growing body of research that connects menstrual cycle patterns with fluctuations in mental health, underscoring the importance of gender‑s…
    STAT · 4mo agoNeutral↗ source