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  • FDA chief Marty Makary resigns, ending turbulent tenure
    FDA chief Marty Makary has resigned, ending a tenure described as turbulent with leadership upheaval, mass layoffs, political pressure and public disputes with drugmakers. President Trump announce…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • Bristol Myers Squibb and China's Hengrui Pharma launch $15.2 billion alliance covering up to 13 early-stage drugs
    Bristol Myers Squibb announced a new partnership with Chinese drugmaker Hengrui Pharma that could be worth more than $15.2 billion and includes up to 13 early-stage drug candidates. The deal refle…
    BioPharma Dive · 3mo agoDealPositive↗ source
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  • Pain drug research gains momentum a year after Vertex launch as new startups revive sodium channel targets
    A year after Vertex introduced its breakthrough pain medication, the field of pain drug development is at a pivotal crossroads. Analysts note that renewed scientific focus and investor interest are…
    BioPharma Dive · 3mo agoPositive↗ source
  • Arvinas and Pfizer license newly approved PROTAC breast cancer drug Veppanu to Rigel Pharmaceuticals
    Arvinas and Pfizer have signed a licensing agreement that transfers ownership of their newly approved breast cancer drug, Veppanu, to San Francisco‑based Rigel Pharmaceuticals. The deal gives Arvi…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • FDA grants breakthrough therapy designation to Emi-Le for advanced adenoid cystic carcinoma
    The U.S. Food and Drug Administration has granted breakthrough therapy designation to Emi-Le for patients with locally advanced, recurrent or metastatic adenoid cystic carcinoma (ACC). Phase 1 tri…
    onclive · 3mo agoCRLPositive↗ source
  • Phase 1 trial shows safety and early PSA responses for novel PSMA radioligand in mCRPC
    A Phase 1 study evaluated the long‑circulating PSMA therapeutic radioligand [177Lu]Lu‑D‑Dan‑Phe‑PSMA in patients with metastatic castration‑resistant prostate cancer. The trial enrolled several dos…
    onclive · 3mo agoPositive readoutPositive↗ source
  • FDA warns of secondary cancers linked to tazemetostat in follicular lymphoma and epithelioid sarcoma
    The FDA issued an alert after the voluntary withdrawal of tazemetostat indications for follicular lymphoma and epithelioid sarcoma, emphasizing the drug's association with secondary primary maligna…
    onclive · 3mo agoRegulatoryNegative↗ source
  • Immunotherapy trials like PODIUM-303 are reshaping treatment for squamous cell anal cancer, says Dr Parikh
    Dr Aparna R. Parikh, an oncologist at Massachusetts General Hospital and Harvard professor, highlighted the growing feasibility of immunotherapy studies in squamous cell anal carcinoma (SCAC). She…
    onclive · 3mo agoPositive↗ source
  • Honesty and Humor Offer Hope in Breast Cancer Survivorship, Says Dr Nunnery and Survivor Annie Bond
    The Breast Cancer Briefing podcast, hosted by Dr Sara Nunnery of Tennessee Oncology, featured a conversation with Annie Bond, a breast cancer survivor and patient advocate. Bond, who was first dia…
    onclive · 3mo agoPositive↗ source
  • Fox Chase Cancer Center and Labcorp launch study of ultra-sensitive blood test for early-stage lung cancer recurrence
    Fox Chase Cancer Center and Labcorp announced a new clinical trial to evaluate a tumor-informed, whole-genome sequencing ctDNA minimal residual disease (MRD) assay for early-stage non-small cell lu…
    onclive · 3mo agoPositive↗ source
  • Experts highlight unmet needs and emerging role of antibody drug conjugates in endometrial cancer
    Experts note that significant unmet needs persist in endometrial cancer even as antibody drug conjugates (ADCs) begin to expand treatment options. They suggest ADCs could address gaps in recurrent…
    onclive · 3mo agoNeutral↗ source
  • Experts discuss emerging therapies shaping the future of relapsed and refractory multiple myeloma
    In a recent opinion segment, Dr. Ajay Nooka and Dr. Noopur Raje explore how new treatments and ongoing trials are influencing the landscape for patients with relapsed and refractory multiple myelom…
    onclive · 3mo agoNeutral↗ source
  • Experts discuss emerging MET-driven resistance data shaping second-line therapy for EGFR-mutated lung cancer
    In a recent video segment, Dr. Jacob Sands sits down with Dr. Heather Wakelee to talk about the impact of new findings on MET-driven resistance in EGFR‑mutated non‑small cell lung cancer. The conv…
    onclive · 3mo agoNeutral↗ source
  • Sequencing antibody-drug conjugates adds complexity to recurrent endometrial cancer treatment
    Therapy sequencing for recurrent endometrial cancer is becoming increasingly complex as immunotherapy moves earlier in the treatment pathway and antibody-drug conjugates (ADCs) gain traction. Expe…
    onclive · 3mo agoNeutral↗ source
  • Experts highlight need for broader monitoring in polycythemia vera as patient shows disease progression despite controlled hematocrit
    A 68-year‑old woman with a six‑year history of polycythemia vera (PV) and prior deep‑vein thrombosis has kept her hematocrit below 45% on hydroxyurea, indicating good control of that metric. Desp…
    onclive · 3mo agoNeutral↗ source
  • AUA and SUO Issue 2026 Update to Advanced Prostate Cancer Guideline
    The American Urological Association (AUA) and the Society of Urologic Oncology (SUO) have released an amendment to their Advanced Prostate Cancer Guideline for 2026. The update revises recommendat…
    onclive · 3mo agoNeutral↗ source
  • Delayed and re-emergent immune-related adverse events can persist years after melanoma checkpoint therapy, says expert
    Dr. Michael A. Postow, chief of the Melanoma Service at Memorial Sloan Kettering Cancer Center, explained that immune checkpoint inhibitors (ICIs) for melanoma have a distinct toxicity profile comp…
    onclive · 3mo agoNeutral↗ source
  • GU oncology experts preview top abstracts slated for ASCO 2026
    The 2026 ASCO Annual Meeting will run from May 29 to June 2 in Chicago, featuring a dedicated genitourinary (GU) oncology program. Leading clinicians were asked what upcoming abstracts they conside…
    onclive · 3mo agoNeutral↗ source
  • Experts discuss emerging role of TROP2-directed ADCs in EGFR-mutated lung cancer
    The segment, part of a series on EGFR‑mutated non‑small cell lung cancer, featured Dr. Jacob Sands together with Drs. Heather Wakelee and Alissa Cooper. They explained that TROP2‑directed antibody…
    onclive · 3mo agoNeutral↗ source
  • Dr. Postow stresses need for long-term multidisciplinary monitoring after melanoma immunotherapy
    Dr. Michael Postow, chief of the Melanoma Service at Memorial Sloan Kettering Cancer Center, emphasizes the importance of long-term multidisciplinary monitoring for patients who have completed immu…
    onclive · 3mo agoNeutral↗ source
  • Experts discuss treatment sequencing after progression in multiple myeloma
    In a recent video segment, Dr. Ajay K. Nooka, Dr. Noopur S. Raje and Dr. Surbhi Sidana lead a discussion on how to approach treatment sequencing for patients whose multiple myeloma has progressed.…
    onclive · 3mo agoNeutral↗ source
  • FDA approves brexu-cel CAR-T therapy for relapsed/refractory mantle cell lymphoma, highlighting safety considerations
    The U.S. Food and Drug Administration has granted approval to brexu-cel, a CAR T-cell therapy, for patients with relapsed or refractory mantle cell lymphoma (MCL). This is the first CAR T indicatio…
    onclive · 3mo agoApprovalPositive↗ source
  • Inhibrx reports 44% response rate when paired with Keytruda in head-and-neck cancer Phase 2 trial
    Inhibrx Biosciences said its experimental agent INBRX-106 boosted the activity of Merck's Keytruda in a Phase 2 study of a head-and-neck cancer. The combination achieved a 44% overall response rate…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Dr. Silbermann highlights trial design priorities for multiple myeloma, from supportive care to diverse enrollment
    Dr. Rebecca Silbermann, an associate professor at Oregon Health & Science University, outlined key considerations for designing multiple myeloma clinical trials. She stressed the importance of alig…
    onclive · 3mo agoNeutral↗ source
  • Zanubrutinib shows longer overall survival than ibrutinib in real-world relapsed/refractory mantle cell lymphoma
    A retrospective real‑world analysis examined outcomes of covalent BTK inhibitors in patients with relapsed or refractory mantle cell lymphoma who received treatment in the second or third line. Th…
    onclive · 3mo agoPositive readoutPositive↗ source