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  • FDA approves Zenbexus for multiple myeloma as NSAI looks to sell MDR notified body unit
    The U.S. Food and Drug Administration has granted approval for Zenbexus to be used in the treatment of multiple myeloma, marking a new therapeutic option for patients with this blood cancer. The a…
    raps · 3d agoApprovalPositive↗ source
  • Abiomed and Oscor advise correction of Impella catheter introducers due to leakage risk
    Abiomed and its partner Oscor have issued a notice about a potential leakage in certain catheter introducer sheaths used with Impella heart pumps. The issue involves 14Fr and 23Fr introducer kits,…
    fda medwatch · 10d agoCRLNeutral↗ source
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fda recalls47
fda medwatch37
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899
Psychiatry & CNS712
Ophthalmology421
Endocrinology & Metabolism380
Pain373
Infectious Disease353
  • Victory Medical Center Pharmacy recalls glutathione vials over high endotoxin levels
    Victory Medical Center Pharmacy in Austin announced a voluntary recall of specific lots of its compounded glutathione 200 mg/mL multi‑dose vials. Testing at the pharmacy detected elevated bacteria…
    fda medwatch · 15d agoCRLNegative↗ source
  • Fresenius Kabi recalls one lot of Morphine Sulfate Injection after labeling error mixes Dilaudid syringes
    Fresenius Kabi announced a voluntary recall of a single lot of its Morphine Sulfate Injection USP, Simplist 2 mg/1 mL product. The recall stems from a labeling mistake where the MicroVault contain…
    fda medwatch · 15d agoCRLNegative↗ source
  • Liebel-Flarsheim recalls OPTIRAY imaging contrast agent after detecting plastic, metal and glass particles
    Liebel-Flarsheim Company announced a recall of one lot of its OPTIRAY Imaging Bulk Package, a 350/500 mL vial of ioversol injection used for intra‑arterial and intravenous imaging. The recall was…
    fda medwatch · 16d agoCRLNegative↗ source
  • Medical Action Industries issues correction for convenience kits with recalled Namic manifolds
    Medical Action Industries has issued a correction notice for certain convenience kits that contain Namic manifolds previously recalled by Medline. The company advises customers to immediately chec…
    fda medwatch · 17d agoCRLNegative↗ source
  • Abiomed recalls 14Fr Low Profile Introducer Kits over thrombus risk
    The FDA has issued an early alert about a recall of Abiomed 14Fr Low Profile Introducer kits, which are used with Impella CP devices. The recall follows a higher‑than‑expected rate of complaints i…
    fda medwatch · 20d agoCRLNegative↗ source
  • American Regent recalls one lot of Papaverine Hydrochloride injection over glass particles
    American Regent announced a voluntary nationwide recall of a single lot of its Papaverine Hydrochloride Injection, USP 60 mg/2 mL, after detecting visible particulate matter. The particles were id…
    fda medwatch · 24d agoCRLNegative↗ source
  • FDA issues early alert on Boston Scientific ENROUTE catheter tip separation risk
    The CDRH has issued an Early Alert warning about a potential high risk issue with Boston Scientific's ENROUTE Transcarotid Neuroprotection System and its Plus version. The problem involves possibl…
    fda medwatch · 27d agoCRLNegative↗ source
  • Bolton Medical Issues Urgent Recall of Relay Pro Thoracic Stent Graft Over Unclasping Fault
    Bolton Medical announced an urgent Class I recall of its Relay Pro Thoracic Stent Graft System, specifically the non-bare stent configuration 32 mm and larger. The recall was triggered because the…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Early Alert: Convenience Kit Issue from Medical Action Industries
    Particulates have the potential to be introduced into blood circulation and become lodged within blood vessels.
    fda medwatch · 1mo ago↗ source
  • Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion Pump
    A software anomaly may cause a false battery-health value. The pump should remain plugged in at all times.
    fda medwatch · 1mo ago↗ source
  • Infusion Pump Correction: Fresenius Kabi Issues Correction for dropped or jarred Ivenix Large Volume Infusion Pumps
    If dropped, the Ivenix pump touchscreen may become unresponsive and should be removed from use.
    fda medwatch · 1mo ago↗ 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
  • Dr Loghavi on the Significance of Updated WHO Diagnostic Criteria for AML in Clinical Practice
    Sanam Loghavi, MD, discusses updated WHO diagnostic criteria for acute myeloid leukemia and its significance for diagnoses and treatment selection.
    onclive · 3mo ago↗ source
  • FDA Approves Decitabine/Cedazuridine Plus Venetoclax in Newly Diagnosed AML
    The FDA has approved oral decitabine/cedazuridine plus venetoclax for newly diagnosed AML unfit for intensive chemo, based on phase 2 ASCERTAIN-V data.
    onclive · 3mo ago↗ source
  • FDA Approves Sonrotoclax for Relapsed/Refractory Mantle Cell Lymphoma
    The FDA granted accelerated approval to sonrotoclax for relapsed/refractory mantle cell lymphoma after at least 2 lines of systemic therapy.
    onclive · 3mo ago↗ source
  • Dr Dinardo on the FDA Approval of Decitabine/Cedazuridine Plus Venetoclax in AML
    Courtney D. DiNardo, MD, MSCE, discusses the FDA approval of decitabine/cedazuridine plus venetoclax in acute myeloid leukemia.
    onclive · 3mo ago↗ source
  • Future Directions in Metastatic Castration-Resistant Prostate Cancer
    Dr. Pedro Barata and Dr. Johann De Bono conclude the discussion by reflecting on the evolving future of radiopharmaceutical therapies in metastatic castration-resistant prostate cancer (mCRPC) and…
    onclive · 3mo ago↗ source
  • Personalized Treatment Decision-Making in Metastatic Castration-Resistant Prostate Cancer
    Dr. Johann De Bono and Dr. Pedro Barata discuss the increasing complexity of personalized treatment decision-making in metastatic castration-resistant prostate cancer (mCRPC) as radiopharmaceutical…
    onclive · 3mo ago↗ source
  • Future Radiopharmaceutical Strategies in Metastatic Castration-Resistant Prostate Cancer
    Dr. Pedro Barata and Dr. Johann De Bono discuss the future direction of radiopharmaceutical therapies and emerging treatment strategies in metastatic castration-resistant prostate cancer (mCRPC).
    onclive · 3mo ago↗ source
  • Safety and Toxicity Management in Metastatic Castration-Resistant Prostate Cancer
    Dr. Johann De Bono and Dr. Pedro Barata discuss practical approaches to monitoring and managing toxicities associated with radiopharmaceutical therapies in metastatic castration-resistant prostate…
    onclive · 3mo ago↗ source
  • Combination and Sequencing Strategies in Metastatic Castration-Resistant Prostate Cancer
    Dr. Pedro Barata and Dr. Johann De Bono discuss ongoing questions surrounding combination approaches and optimal sequencing strategies for radiopharmaceutical therapies in metastatic castration-res…
    onclive · 3mo ago↗ source
  • Treatment Sequencing in Metastatic Castration-Resistant Prostate Cancer
    Dr. Johann De Bono and Dr. Pedro Barata discuss the evolving role of treatment sequencing and patient selection for radiopharmaceuticals in metastatic castration-resistant prostate cancer (mCRPC).
    onclive · 3mo ago↗ source
  • Patient Selection for Radiopharmaceuticals in Metastatic Castration-Resistant Prostate Cancer
    Dr. Pedro Barata and Dr. Johann De Bono discuss how patient selection and disease characteristics influence the use of radiopharmaceuticals in metastatic castration-resistant prostate cancer (mCRPC).
    onclive · 3mo ago↗ source