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1,103 stories matching this filter · ← front page

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  • Regeneron immunotherapy combo comes up short in melanoma trial
    A two-drug regimen of Regeneron’s fianlimab and Libtayo didn’t significantly outperform Keytruda in a late-stage study, a finding that surprised Wall Street analysts and wiped out billions in marke…
    BioPharma Dive · 2mo ago↗ source
  • Regeneron's Phase 3 skin cancer miss adds to mounting failures in LAG-3
    Regeneron Pharmaceuticals’ LAG-3 inhibitor called fianlimab has flunked a late-stage skin cancer trial, marking yet another blow for the drug class. The announcement follows a spate of recent clini…
    Endpoints · 2mo ago↗ source
  • FDA approves AstraZeneca’s baxdrostat for certain patients with hypertension
    One of the key products underpinning AstraZeneca’s goal of hitting $80 billion in revenue by 2030 has been approved by the FDA, the drugmaker said Monday. The blood ...
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Endpoints · 2mo ago
↗ source
  • Unlocking more value from mature drug products through strategic outsourcing
    See how strategic outsourcing can maximize value and reduce costs for mature drug portfolios.
    BioPharma Dive · 2mo ago↗ source
  • Dr Meeks on a Real-World Study of BCG Retreatment After BCG Failure in NMIBC
    Joshua J. Meeks, MD, PhD, discusses data from a real-world study of BCG retreatment after BCG failure in NMIBC.
    onclive · 2mo ago↗ source
  • Dr Hafron on a Multidisciplinary Quality Initiative Designed to Mitigate the AEs of ADT in Prostate Cancer
    Jason Hafron, MD, discusses findings from a study that evaluated the implementation of a multidisciplinary quality initiative in prostate cancer.
    onclive · 2mo ago↗ source
  • Preoperative Intravesical Mitomycin-C Before TURBT Cuts Recurrence Risk by 77% in NMIBC Over 5 Years
    Two doses of intravesical mitomycin-C administered before TURBT produced a 77% reduction in the risk of recurrence or death vs TURBT alone in NMIBC.
    onclive · 2mo ago↗ source
  • Genomic Disease Burden Markers, PD-L1 Expression Predictive of pOR With Neoadjuvant Gem-iDRS ± Cetrelimab in MIBC
    A biomarker analysis of SunRISe-4 found that high baseline TMB, GBD, and PD-L1 expression were associated with pathologic overall response to the regimen.
    onclive · 2mo ago↗ source
  • Makary resigns; Biogen reports Alzheimer’s data; and more
    Welcome back to Endpoints Weekly. The biggest news this week was Marty Makary’s resignation from his role as FDA Commissioner. The announcement came days after reports emerged that President Donald…
    Endpoints · 2mo ago↗ source
  • Dr Croll on Radiographic Size Change vs irRVT After Neoadjuvant Therapy in RCC
    Benjamin Croll, MD, discusses findings from a study of the correlation between radiographic response and pathologic response in RCC.
    onclive · 2mo ago↗ source
  • FDA Approves T-DXd for Early-Stage HER2+ Breast Cancer
    The FDA approved trastuzumab deruxtecan for the adjuvant and neoadjuvant treatment of select early-stage HER2-positive breast cancer.
    onclive · 2mo ago↗ source
  • Dr Garzotto on Aglatimagene Besadenovec Plus Valacyclovir and EBRT in Localized Prostate Cancer
    Mark Garzotto, MD, discusses efficacy data with aglatimagene besadenovec plus valacyclovir and EBRT in localized prostate cancer.
    onclive · 2mo ago↗ source
  • Dr Cirstea on Sequencing Considerations in R/R Multiple Myeloma
    Diana Cirstea, MD, discusses sequencing considerations in relapsed/refractory multiple myeloma in the era of T-cell–redirecting therapies.
    onclive · 2mo ago↗ source
  • Dr Hafron on the FDA Approval of Adjuvant Atezolizumab in MRD+ MIBC
    Jason Hafron, MD, discusses the significance of the FDA approval of adjuvant atezolizumab for MRD+ muscle-invasive bladder cancer.
    onclive · 2mo ago↗ source
  • CDER chief Høeg fired from FDA as other top roles turn over
    The leader of the FDA's drug division, Tracy Beth Høeg, is expected to depart, as part of a broad shakeup at the top of the agency after the exit of now-former Commissioner Marty Makary, according ...
    Endpoints · 2mo ago↗ source
  • Durvalumab Plus BCG Reduces High-Risk NMIBC Recurrence or Death Risk by 32% in Phase 3 POTOMAC Trial
    Durvalumab plus BCG induction and maintenance yielded an HR of 0.68 vs BCG alone for DFS in BCG-naive, high-risk non–muscle-invasive bladder cancer.
    onclive · 2mo ago↗ source
  • Darolutamide Plus ADT Yields Significant OS Benefit in mHSPC
    Darolutamide plus ADT demonstrated a 50% reduction in the risk of death in metastatic hormone-sensitive prostate cancer.
    onclive · 2mo ago↗ source
  • OncLive Weekly News Quiz (5/15/2026): Did You Catch 3 New FDA Oncology Approvals?
    Did you catch all of this week's top oncology news? Test your knowledge with OncLive's Weekly News Quiz.
    onclive · 2mo ago↗ source
  • Pembrolizumab Plus BCG Elicits 92% CR Rate in BCG-Naive Very High-Risk T1 NMIBC
    Pembrolizumab plus BCG achieved a 92% 6-month complete response rate in very high-risk T1 bladder cancer with no progression to muscle-invasive disease.
    onclive · 2mo ago↗ source
  • Biopharma M&A maintains strength even as large deals wane
    Biopharma's deals landscape could hardly be better, as large companies take a multi-pronged approach to withstand an avalanche of major patent expiries. But there’s one notable missing piece: megad…
    Endpoints · 2mo ago↗ source
  • Amgen expands crackdown on what it says is misuse of 340B program
    Amgen is expanding its claims data requirements for pharmacies dispensing its drugs under the 340B federal drug discount program. The company said the new policy addresses what it claims is fraud a…
    Endpoints · 2mo ago↗ source
  • FDA Approves Adjuvant Atezolizumab for MRD+ Muscle-Invasive Bladder Cancer
    The FDA approved adjuvant atezolizumab for muscle-invasive bladder cancer with circulating tumor DNA molecular residual disease.
    onclive · 2mo ago↗ source
  • Detalimogene Voraplasmid Yields 54% CR Rate in Heavily Pretreated BCG-Unresponsive NMIBC With CIS
    TRAEs were generally reversible and low grade, and 96.8% of patients remained free from progression to T2 or greater disease at the data cutoff.
    onclive · 2mo ago↗ source
  • Roswell Park Team Members Take Part in Global Conference Dedicated to Indigenous Peoples and Cancer
    Members of Roswell Park Comprehensive Cancer Center participated in the 2026 World Indigenous Cancer Conference.
    onclive · 2mo ago↗ source
  • FDA hold puts Aardvark Prader-Willi drug in limbo
    The company plans to unblind the late-stage study that was halted due to safety concerns, which could lead to an overhaul of its entire development program.
    BioPharma Dive · 2mo ago↗ source