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980 stories matching this filter · ← front page

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  • Baxter issues urgent correction for Volara breathing device circuits due to leak risk
    Baxter has sent an Urgent Medical Device Correction notice to customers using its Volara Positive Pressure Breathing System, advising that all patient circuits be corrected before further use. The…
    fda medwatch · 4mo agoCRLNegative↗ 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 · 3mo agoNeutral↗ source
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fda medwatch111
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Ophthalmology1051
Pain777
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Nephrology760
  • 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 · 4mo agoPositive↗ source
  • Medtronic recalls Harmony delivery catheter system after tip detachment risk
    Medtronic has issued a recall of certain lots of its Harmony Delivery Catheter System (DCS), which is used to implant the Harmony transcatheter pulmonary valve. The FDA classified the recall as th…
    fda medwatch · 4mo agoCRLNegative↗ source
  • FDA issues early alert on non‑sterile BD ChloraPrep applicators in Medline convenience kits
    FDA CDRH issued an early alert about a potentially high‑risk device issue involving BD ChloraPrep applicators in Medline convenience kits that may not be sterile. Medline sent a letter on June 12…
    fda medwatch · 4mo agoRegulatoryNegative↗ source
  • Medical Action Industries issues recall of convenience kits due to risk of particulate contamination
    The FDA’s Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with a Medical Action Industries convenience kit. The alert says that particulates coul…
    fda medwatch · 4mo agoCRLNegative↗ source
  • Fresenius Kabi issues correction for Ivenix infusion pumps over battery health software bug
    The U.S. Food and Drug Administration has classified a correction for Fresenius Kabi’s Ivenix Large Volume infusion pump as the most serious type of recall. The action does not require removal of t…
    fda medwatch · 4mo agoCRLNegative↗ source
  • Fresenius Kabi urges removal of dropped Ivenix infusion pumps after safety correction
    Fresenius Kabi has issued a safety notice for its Ivenix large-volume infusion pumps. The FDA classified the issue as a Class I recall, the most serious level, because the touchscreen can become un…
    fda medwatch · 4mo agoCRLNegative↗ source
  • Windstone Medical issues correction for non-sterile alcohol prep pads in custom convenience kits
    Windstone Medical Packaging, Inc. has released a correction notice for several custom convenience kits that include Cardinal Health Webcol large alcohol prep pads that were found to be non-sterile.…
    fda medwatch · 4mo agoCRLNegative↗ source
  • Abiomed recalls Impella CP Sets with SmartAssist over low purge pressure risk
    Abiomed has issued a recall of specific Impella CP Sets with SmartAssist after discovering that the units do not meet design specifications. The defect can cause low purge pressure events from the…
    fda medwatch · 4mo agoCRLNegative↗ source
  • Hamilton Medical issues updated use instructions for certain breathing circuit sets after serious recall
    Hamilton Medical has sent a letter to customers on May 18, 2026, advising updated use instructions for specific coaxial breathing circuit sets used with its HAMILTON-C1, HAMILTON T-1 and HAMILTON-M…
    fda medwatch · 4mo agoCRLNegative↗ 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 · 4mo agoNeutral↗ source
  • Biopharma manufacturers turn to flexible, modular facilities to meet diverse therapy demands
    Biopharma development is increasingly focused on specialized and personalized treatments such as cell and gene therapies, antibody-drug conjugates and monoclonal antibodies. At the same time, the m…
    Fierce Biotech · 4mo agoPositive↗ 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
  • 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
  • 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