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908 stories matching this filter · ← front page

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  • Stakeholders urge FDA to create drug-repurposing framework that avoids disincentives and stays within authority
    Stakeholders, including patients and healthcare industry groups, told the FDA that repurposing existing drugs offers significant opportunities for new treatments. They warned that any new repurpos…
    raps · 1mo agoRegulatoryNeutral↗ source
  • EMA issues guidance to curb microbial contamination in non-sterile medicines; MHRA reports record drug approvals
    The European Medicines Agency has issued new guidance that outlines technical and organisational measures to reduce the risk of microbial contamination in non-sterile pharmaceutical products. The…
    raps · 1mo agoRegulatoryNeutral↗ source
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  • Cue Biopharma appoints Dominic Borie as chief medical officer and head of R&D
    Cue Biopharma announced the hiring of Dr. Dominic Borie, MD, PhD, as its new chief medical officer and head of research and development. Borie joins from Kyverna Therapeutics, where he served as a…
    Fierce Biotech · 1mo agoPositive↗ source
  • UK regulator reports rise in drug approvals and steps toward AI oversight in healthcare
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) released its 2025-2026 annual report to Parliament. The agency highlighted that it approved more new medicines this year than in t…
    raps · 1mo agoRegulatoryNeutral↗ source
  • ‘Substantially better than before’: Why India has golden opportunity to build on innovative R&D wins
    A string of recent wins on the frontiers of novel drug development could mean that a homegrown innovation industry is within reach.
    Fierce Biotech · 1mo agoNeutral↗ source
  • Merck-Kelun ADC sac-TMT shows progression-free survival benefit with Keytruda in late-stage NSCLC trial
    Kelun-Biotech announced that its antibody‑drug conjugate sac‑TMT, developed with Merck, achieved positive Phase 3 results when paired with Keytruda in a non‑small cell lung cancer trial. The data…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • J&J restructures pharma supply chain, offloading sites as part of $55 B U.S. manufacturing push
    Johnson & Johnson announced it is restructuring its pharmaceutical supply chain, offloading certain sites to streamline operations as part of its $55 billion U.S. manufacturing initiative. The cha…
    BioSpace · 1mo agoPositive↗ source
  • Nobel laureate Jennifer Doudna unveils AI-driven platform to design novel gene‑editing enzymes
    Jennifer Doudna, the Nobel laureate who co‑invented CRISPR, announced a new AI‑powered platform for creating gene‑editing proteins in a paper published today in Science. The system uses computation…
    Fierce Biotech · 1mo agoPositive↗ source
  • Lonza urges biotech firms to prioritize early de-risking to streamline IND path
    In a recent interview, Jaime Okray of Lonza highlighted that emerging biotech companies are shifting focus from pure speed to early identification of development risks as they aim for an IND filing…
    Fierce Biotech · 1mo agoPositive↗ source
  • Agentic AI poised to reshape clinical development by moving beyond tools to autonomous decision-making
    Earlier this year, a colleague argued that clinical leaders should stop asking whether they have an 'AI strategy', because the question often leads to the wrong conversation. Instead, leaders are…
    Fierce Biotech · 1mo agoPositive↗ source
  • FDA acting commissioner says Makary’s journal policies are not official guidance; UK regulator reports rise in drug approvals and AI steps
    The acting commissioner of the U.S. Food and Drug Administration clarified that the policies published in medical journals by former commissioner Marty Makary do not constitute official FDA policy…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Axiom's stem cell therapy shows zero mortality in phase-1 trial for newborn brain injuries
    Axiom Biosciences reported that its mesenchymal stem cell (MSC) therapy achieved a 0% mortality rate over two years in a phase‑1 study of newborns with severe brain injuries. The nine‑patient trial…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Experts say MDUFA VI draft letter improves program while addressing FDA resource limits
    Industry experts note that the draft commitment letter for the upcoming Medical Device User Fee Amendments (MDUFA VI) offers enhancements over the current framework and takes into account the FDA’s…
    raps · 1mo agoRegulatoryNeutral↗ source
  • BIO 2026 in San Diego features executive interviews on biotech trends and opportunities
    The BIO International Convention gathered more than 20,000 life‑science leaders in San Diego, serving as a major forum for biotech discussion. During the event, Fierce conducted a series of video…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Ohio launches $30M Life Science Training Center to boost biomanufacturing workforce
    Ohio’s JobsOhio agency and the Ohio Life Sciences Association announced a public-private training center backed by up to $30 million. The center is intended to create a statewide pipeline of operat…
    Fierce Biotech · 1mo agoPositive↗ source
  • Precision strategies help de-risk rare disease therapy launches
    Commercializing a rare disease therapy presents a high‑risk, high‑reward scenario for biotech firms. Small patient populations, stringent regulatory requirements, and the need to sustain value beyo…
    Fierce Biotech · 2mo agoNeutral↗ 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 · 3mo agoPositive readoutPositive↗ 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 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