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2,067 stories matching this filter · ← front page

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  • Darolutamide with ADT cuts death risk by half in metastatic hormone‑sensitive prostate cancer
    A recent study evaluated darolutamide combined with androgen deprivation therapy in patients with metastatic hormone‑sensitive prostate cancer. The trial reported a 50% reduction in the risk of dea…
    onclive · 3mo agoPositive readoutPositive↗ source
  • FDA approves adjuvant atezolizumab for MRD-positive muscle-invasive bladder cancer
    The U.S. Food and Drug Administration has granted approval for adjuvant atezolizumab in patients with muscle‑invasive bladder cancer who test positive for circulating tumor DNA, indicating molecula…
    onclive · 3mo agoApprovalPositive↗ source
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  • FDA places clinical hold on Aardvark’s Prader-Willi drug amid heart safety concerns
    The Food and Drug Administration has issued a clinical hold on Aardvark Therapeutics' experimental treatment ARD-101 for Prader-Willi Syndrome after safety signals were identified. The hold follow…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • Biotech execs push for Rick Pazdur as FDA chief while Takeda announces 4,500 layoffs
    Hundreds of biotechnology executives, investors and patient advocates have signed a petition urging President Trump to nominate Rick Pazdur as the next FDA commissioner. Pazdur, a longtime FDA vet…
    BioPharma Dive · 3mo agoLayoffsNeutral↗ source
  • Expert outlines sequencing strategies for relapsed/refractory multiple myeloma amid rise of T-cell redirecting therapies
    Dr. Diana Cirstea, a specialist in multiple myeloma, explained how treatment sequencing is evolving for patients with relapsed or refractory disease. She highlighted that the growing availability o…
    onclive · 3mo agoNeutral↗ source
  • FDA drug division chief Tracy Beth Høeg expected to depart amid leadership shakeup
    Tracy Beth Høeg, who leads the FDA’s Center for Drug Evaluation and Research, is reported to be leaving the agency. Her exit comes shortly after former Commissioner Marty Makary stepped down, sugg…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Pembrolizumab with BCG shows 92% 6-month complete response in very high-risk T1 bladder cancer
    A clinical study evaluated the combination of pembrolizumab and bacillus Calmette-Guérin (BCG) in patients with very high-risk T1 non-muscle invasive bladder cancer who had not previously received…
    onclive · 3mo agoPositive readoutPositive↗ source
  • Detalimogene Voraplasmid Achieves 54% Complete Response in BCG-Unresponsive Bladder Cancer
    A clinical study of detalimogene voraplasmid reported a 54% complete response rate in patients with heavily pretreated, BCG‑unresponsive non‑muscle‑invasive bladder cancer that also had carcinoma i…
    onclive · 3mo agoPositive readoutPositive↗ source
  • Supreme Court blocks lower court ruling, keeps mail-order access to abortion pill mifepristone
    The Supreme Court issued an indefinite stay that preserves mail-order access to the abortion medication mifepristone. The order maintains the ability for providers to prescribe the drug through pha…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ source
  • Candel Therapeutics shares 20-month follow-up data for its prostate cancer candidate ahead of FDA filing
    Candel Therapeutics announced that it has completed a long-term follow‑up study of patients treated with its prostate cancer drug. The data extend to about 20 months after treatment and are intende…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • FDA Commissioner Marty Makary Resigns After Turbulent Tenure
    Marty Makary stepped down as commissioner of the U.S. Food and Drug Administration on Tuesday, ending a period marked by controversy and intense scrutiny. His resignation follows a series of publi…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • Mid-size pharma firms drive surge in biopharma M&A activity
    The article notes that 2026 is shaping up as one of the busiest years for biopharma mergers and acquisitions on record. Unlike previous years dominated by large multinational companies, a broader…
    Endpoints · 3mo agoDealNeutral↗ source
  • Prevention and personalized skin care highlighted as future direction for melanoma oncodermatology
    Dr. Beth McLellan, a dermatologist, emphasizes that preventing radiation-induced skin damage is becoming a central focus in melanoma care. She also points out the need for equitable access to scal…
    onclive · 3mo agoPositive↗ source
  • Biopharma M&A stays robust as companies shift focus from megadeals to smaller targets
    The article notes that despite a slowdown in large megadeals, overall merger and acquisition activity in the biopharma sector remains strong. Companies are adopting multi‑pronged strategies to add…
    Endpoints · 3mo agoDealNeutral↗ source
  • Amgen tightens 340B program rules, expanding pharmacy claims data requirements
    Amgen announced it is expanding the data it requires from pharmacies that dispense its products under the federal 340B drug discount program. The new policy will obligate participating pharmacies…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Aardvark to unblind rare disease trial after FDA places full clinical hold; Alumis issues verdict on Acelyrin asset
    Aardvark's rare disease candidate is under a full clinical hold by the FDA, which has paused all dosing and data collection. The company says it intends to unblind the trial data despite the hold,…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • OncLive poll highlights top GI cancer abstracts and interest areas for ASCO 2026
    OncLive conducted a poll among its audience to gauge which gastrointestinal cancer abstracts are expected to generate the most interest at the upcoming ASCO Annual Meeting. The poll results identi…
    onclive · 3mo agoNeutral↗ source
  • Supreme Court Keeps Mail Delivery of Abortion Pill Mifepristone in Place
    The Supreme Court issued a ruling on Thursday that preserves the ability to ship the abortion medication mifepristone through the postal service. The decision leaves in place the existing safety r…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Dr Croll reviews study linking tumor size changes on scans to pathological outcomes after neoadjuvant therapy in kidney cancer
    Dr Benjamin Croll, MD, presented findings from a recent investigation into the relationship between radiographic size changes and pathological response in renal cell carcinoma patients receiving ne…
    onclive · 3mo agoNeutral↗ source
  • Dr Garzotto reviews efficacy of aglatimagene besadenovec with valacyclovir and radiation in localized prostate cancer
    Dr Mark Garzotto presented data on a novel therapeutic approach for localized prostate cancer that combines the gene therapy agent aglatimagene besadenovec with the antiviral drug valacyclovir and…
    onclive · 3mo agoNeutral↗ source
  • AC Immune CEO Andrea Pfeifer Retires After 23 Years, Company Begins CEO Search
    AC Immune announced that its chief executive Andrea Pfeifer will step down after a 23‑year tenure. Pfeifer, who has guided the biotech through multiple development programs, said she will retire a…
    Endpoints · 3mo agoNeutral↗ source
  • Nonprofits launch Zillow-style marketplace to match abandoned gene and cell therapies with new developers
    Two nonprofit groups announced the launch of an online marketplace designed to give abandoned cell and gene therapy projects a chance for redevelopment. The platform, unveiled at the American Socie…
    Endpoints · 3mo agoPositive↗ source
  • GU experts poll top abstract topics for ASCO 2026 meeting
    A poll of genitourinary oncology specialists was conducted to gauge interest in upcoming ASCO 2026 abstracts. Participants used OncLive’s social media platform to nominate the abstracts they expec…
    onclive · 3mo agoNeutral↗ source
  • Roswell Park Researchers Join 2026 World Indigenous Cancer Conference
    Roswell Park Comprehensive Cancer Center staff took part in the 2026 World Indigenous Cancer Conference, a global gathering focused on cancer issues affecting Indigenous peoples. The conference br…
    onclive · 3mo agoPositive↗ source
  • OncLive launches weekly quiz on recent FDA oncology approvals
    OncLive released a weekly news quiz dated May 15, 2026, inviting readers to test their knowledge of recent oncology developments. The quiz focuses on three new FDA approvals in the oncology space…
    onclive · 3mo agoNeutral↗ source