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  • Amgen defends Tavneos as FDA, European regulators and Japanese doctors raise safety concerns
    Amgen said it continues to support its rare-disease therapy Tavneos despite recent safety alerts. The U.S. FDA has indicated it wants the drug removed from the market after a report of 20 deaths l…
    Endpoints · 5mo agoRegulatoryNegative↗ source
  • Merck and Kelun-Biotech's ADC sac-TMT secures first global Phase 3 win ahead of schedule
    Merck and China-based Kelun-Biotech reported that their experimental antibody-drug conjugate sac-TMT achieved a positive outcome in a global Phase 3 study, marking the first such success for the ca…
    Endpoints · 5mo agoPositive readoutPositive↗ source
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  • Republican lawmaker releases FDA analysis of alleged pediatric Covid vaccine deaths
    A Republican congressman has made public an analysis that the FDA commissioned to examine claims of child deaths linked to Covid-19 vaccines. The study was initiated by former senior FDA officials…
    Endpoints · 5mo agoRegulatoryNeutral↗ source
  • Regeneron signs up to $125 million deal with Parabilis to target difficult drug targets
    Regeneron announced a deal with Parabilis Medicines valued up to $2.2 billion, with an upfront payment of $125 million. The agreement aims to give Regeneron access to Parabilis’s platform that dis…
    Endpoints · 5mo agoDealNeutral↗ source
  • Regeneron's LAG-3 inhibitor fianlimab fails Phase 3 skin cancer trial
    Regeneron announced that its experimental LAG-3 inhibitor fianlimab did not meet its primary endpoint in a late-stage trial for a skin cancer indication. The Phase 3 study was designed to evaluate…
    Endpoints · 5mo agoNegative readoutNegative↗ source
  • Design Therapeutics reports early Friedreich's ataxia trial shows 6.4-point improvement; Vincentage reports Chinese obesity data
    Design Therapeutics disclosed Phase 1/2 results for its Friedreich's ataxia candidate DT-216P2. The trial administered a 1 mg/kg dose and reported an average 6.4-point improvement on the study endp…
    Endpoints · 5mo agoPositive readoutPositive↗ source
  • Supreme Court declines to hear pharma challenges to Medicare drug price negotiations
    The U.S. Supreme Court has refused to review several lawsuits filed by drug makers contesting the Medicare drug price negotiation provisions of the Inflation Reduction Act. The cases, brought by co…
    Endpoints · 5mo agoRegulatoryNeutral↗ source
  • Preoperative intravesical mitomycin C cuts NMIBC recurrence risk by 77% over five years
    A recent study evaluated giving two doses of intravesical mitomycin C before transurethral resection of bladder tumor (TURBT) in patients with non‑muscle‑invasive bladder cancer (NMIBC). Compared…
    onclive · 5mo agoPositive readoutPositive↗ source
  • FDA Commissioner Marty Makary resigns as Biogen unveils new Alzheimer’s data
    Marty Makary announced his resignation from the role of FDA commissioner, ending his tenure amid recent political developments. Biogen disclosed fresh data from its Alzheimer’s disease program, ad…
    Endpoints · 5mo agoRegulatoryNeutral↗ source
  • High TMB, GBD and PD-L1 Levels Linked to Better Response in Neoadjuvant Gem-iDRS or Cetrelimab Trial for Bladder Cancer
    The SunRISe-4 trial evaluated neoadjuvant gemcitabine‑based immunotherapy with or without cetrelimab in patients with muscle‑invasive bladder cancer. A biomarker sub‑analysis showed that patients…
    onclive · 5mo agoPositive readoutPositive↗ source
  • Expert reviews real-world data on BCG retreatment after failure in non-muscle-invasive bladder cancer
    Dr Joshua J. Meeks, MD, PhD, provided an overview of a real-world study that examined the use of BCG retreatment in patients with non‑muscle‑invasive bladder cancer (NMIBC) who had previously faile…
    onclive · 5mo agoNeutral↗ source
  • Multidisciplinary quality program shown to cut side effects of androgen deprivation therapy in prostate cancer
    Dr Hafron discussed a recent study that evaluated a multidisciplinary quality initiative aimed at reducing adverse events linked to androgen deprivation therapy for prostate cancer. The program co…
    onclive · 5mo agoPositive readoutPositive↗ source
  • FDA approves trastuzumab deruxtecan for early-stage HER2-positive breast cancer
    The U.S. Food and Drug Administration has granted approval for trastuzumab deruxtecan (T‑DXd) as a treatment option in both the adjuvant and neoadjuvant settings for certain patients with early-sta…
    onclive · 5mo agoApprovalPositive↗ source
  • FDA approves adjuvant atezolizumab for MRD-positive muscle-invasive bladder cancer, says Dr. Hafron
    The U.S. Food and Drug Administration has granted approval for adjuvant atezolizumab in patients with MRD-positive muscle-invasive bladder cancer. The decision expands the use of the immunotherapy…
    onclive · 5mo agoApprovalPositive↗ source
  • Durvalumab combined with BCG cuts recurrence risk by 32% in phase 3 trial for high-risk non-muscle-invasive bladder cancer
    A phase 3 study called POTOMAC tested durvalumab together with BCG induction and maintenance against BCG alone in patients who had not previously received BCG and who have high-risk non-muscle-inva…
    onclive · 5mo agoPositive readoutPositive↗ source
  • 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 · 5mo 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 · 5mo agoApprovalPositive↗ 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo agoPositive readoutPositive↗ 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo agoPositive↗ source