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579 stories matching this filter · ← front page

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  • 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
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fda recalls45
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Psychiatry & CNS724
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Endocrinology & Metabolism389
Infectious Disease361
  • FDA issues early alert on Resmed Astral ventilators due to electrical component failure risk
    The FDA’s Center for Devices and Radiological Health has released an early alert warning about a possible high-risk problem with certain Resmed Astral ventilators. A defective electrical component…
    fda medwatch · 1mo agoRegulatoryNegative↗ 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
  • 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
  • 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 · 1mo agoCRLNegative↗ 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoCRLNegative↗ source
  • Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for Convenience Kit
    Certain Cardinal Health Webcol Large Alcohol Prep Pads in Custom Convenience Kits manufactured by Aligned Medical Solutions are not sterile.
    fda medwatch · 1mo ago↗ source
  • Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssist
    Specific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case
    fda medwatch · 1mo ago↗ source
  • Breathing Circuit Set Correction: Hamilton Medical Updates Use Instructions for Breathing Circuit Set
    The ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation.
    fda medwatch · 1mo ago↗ source
  • Dr Meeks on a Real-World Study of BCG Retreatment After BCG Failure in NMIBC
    Joshua J. Meeks, MD, PhD, discusses data from a real-world study of BCG retreatment after BCG failure in NMIBC.
    onclive · 3mo ago↗ source
  • Dr Hafron on a Multidisciplinary Quality Initiative Designed to Mitigate the AEs of ADT in Prostate Cancer
    Jason Hafron, MD, discusses findings from a study that evaluated the implementation of a multidisciplinary quality initiative in prostate cancer.
    onclive · 3mo ago↗ source
  • Preoperative Intravesical Mitomycin-C Before TURBT Cuts Recurrence Risk by 77% in NMIBC Over 5 Years
    Two doses of intravesical mitomycin-C administered before TURBT produced a 77% reduction in the risk of recurrence or death vs TURBT alone in NMIBC.
    onclive · 3mo ago↗ source
  • Genomic Disease Burden Markers, PD-L1 Expression Predictive of pOR With Neoadjuvant Gem-iDRS ± Cetrelimab in MIBC
    A biomarker analysis of SunRISe-4 found that high baseline TMB, GBD, and PD-L1 expression were associated with pathologic overall response to the regimen.
    onclive · 3mo ago↗ source
  • Dr Croll on Radiographic Size Change vs irRVT After Neoadjuvant Therapy in RCC
    Benjamin Croll, MD, discusses findings from a study of the correlation between radiographic response and pathologic response in RCC.
    onclive · 3mo ago↗ source
  • FDA Approves T-DXd for Early-Stage HER2+ Breast Cancer
    The FDA approved trastuzumab deruxtecan for the adjuvant and neoadjuvant treatment of select early-stage HER2-positive breast cancer.
    onclive · 3mo ago↗ source
  • Dr Garzotto on Aglatimagene Besadenovec Plus Valacyclovir and EBRT in Localized Prostate Cancer
    Mark Garzotto, MD, discusses efficacy data with aglatimagene besadenovec plus valacyclovir and EBRT in localized prostate cancer.
    onclive · 3mo ago↗ source
  • Dr Cirstea on Sequencing Considerations in R/R Multiple Myeloma
    Diana Cirstea, MD, discusses sequencing considerations in relapsed/refractory multiple myeloma in the era of T-cell–redirecting therapies.
    onclive · 3mo ago↗ source
  • Dr Hafron on the FDA Approval of Adjuvant Atezolizumab in MRD+ MIBC
    Jason Hafron, MD, discusses the significance of the FDA approval of adjuvant atezolizumab for MRD+ muscle-invasive bladder cancer.
    onclive · 3mo ago↗ source
  • Durvalumab Plus BCG Reduces High-Risk NMIBC Recurrence or Death Risk by 32% in Phase 3 POTOMAC Trial
    Durvalumab plus BCG induction and maintenance yielded an HR of 0.68 vs BCG alone for DFS in BCG-naive, high-risk non–muscle-invasive bladder cancer.
    onclive · 3mo ago↗ source
  • Darolutamide Plus ADT Yields Significant OS Benefit in mHSPC
    Darolutamide plus ADT demonstrated a 50% reduction in the risk of death in metastatic hormone-sensitive prostate cancer.
    onclive · 3mo ago↗ source