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68 stories matching this filter · ← front page

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  • FDA issues early alert on CooperSurgical infant nasal CPAP devices with loose tubing connection
    The FDA’s Center for Devices and Radiological Health has posted an Early Alert about a potential high-risk issue with certain CooperSurgical infant nasal CPAP devices. The problem involves a loose…
    fda medwatch · 1d agoRegulatoryNegative↗ source
  • Early Alert: Nitric Oxide Delivery System Issue from NOxBOX
    The NOxBOX NOxBOXi System may leak oxygen during inhaled nitric oxide therapy
    fda medwatch · 1d agoRegulatoryNeutral↗ source
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Infectious Disease379
  • FDA alerts recall of Medline neonatal heated wire breathing circuits over connector failures
    The FDA's Center for Devices and Radiological Health issued an Early Alert to warn the public about a high‑risk issue with Medline's neonatal and infant heated wire breathing circuits. The problem…
    fda medwatch · 4d agoCRLNegative↗ source
  • FDA schedules hearing on Concerta generic withdrawal as Ivonescimab secures first-line lung cancer indication in China
    The U.S. Food and Drug Administration has granted a hearing to consider the withdrawal of a generic version of Concerta. The hearing will address regulatory concerns surrounding the product. In Ch…
    raps · 12d agoRegulatoryNeutral↗ source
  • Hamilton Medical issues recall of coaxial breathing circuit sets for C1, T-1 and MR1 ventilators
    Hamilton Medical has recalled specific coaxial breathing circuit sets used with its C1, T-1 and MR1 ventilators after the FDA classified the issue as a Class I recall, the most serious level, due t…
    fda medwatch · 14d agoCRLNegative↗ source
  • Fresenius Kabi recalls Tyenne (tocilizumab-aazg) 400 mg injection vials over glass particle contamination
    Fresenius Kabi announced a recall of a specific lot of its Tyenne (tocilizumab-aazg) injection, 400 mg/20 mL vials, after detecting glass particles in the product. The company said the contaminati…
    fda medwatch · 14d agoCRLNegative↗ source
  • Medline recalls Hudson RCI neonatal heated wire breathing circuits over connector overheating risk
    Medline Industries announced a nationwide recall of its Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits. The recall was triggered after the company received reports of sporadic failures i…
    fda medwatch · 19d agoRegulatoryNegative↗ 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 · 20d agoCRLNegative↗ source
  • Lilly expands access to its experimental obesity therapy while Jazz pulls Zepzelca's second-line lung cancer use
    Lilly announced it will broaden the expanded‑access program for its obesity drug that has not yet received regulatory approval, allowing more patients to receive the treatment under a compassionate…
    raps · 21d agoRegulatoryNeutral↗ 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 · 29d agoCRLNegative↗ 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
  • 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 · 1mo agoCRLNegative↗ source
  • FDA picks seven firms for PreCheck pilot to boost U.S. drug manufacturing
    The FDA announced on June 29, 2026 that seven companies have been chosen for its PreCheck Pilot Program, an initiative aimed at strengthening U.S. drug manufacturing and supply chain resilience. T…
    fda press · 1mo agoRegulatoryPositive↗ source
  • MET Alterations in NSCLC: Amplification, Mutations, and Therapeutic Strategies
    Decode MET-altered lung cancer: amplification, exon 14 skipping and co-mutations, plus evolving targeted therapies and tumor board insights.
    onclive · 3mo ago↗ source
  • UCSF Receives Major Gift to Advance Research and Modernization
    Kathy Chiao and Ken Hao commit $100 million for major capital projects, cancer research, and innovation at UCSF — building on a recent $75 million gift to UC Davis for veterinary medicine.
    onclive · 3mo ago↗ source
  • How Reimagined Research Endeavors Intersect With Dignified End-of-Life Care: With D. Ross Camidge, MD, PhD; and Charles D. Blanke, MD, FACP, FASCO
    Drs Camidge and Blanke discuss Dr Blanke's career path from pioneering targeted cancer therapies to becoming a leading advocate for medical aid in dying.
    onclive · 3mo ago↗ source
  • Dr Postow on the Timing of Delayed or Re-Emergent irAEs in Melanoma
    Michael A. Postow, MD, discusses the evolving understanding of ICIs in melanoma and the unique toxicity profiles associated with these agents.
    onclive · 3mo ago↗ source
  • Temple Health’s Fox Chase Cancer Center and Labcorp Collaborate to Test Ultra-Sensitive Blood-Based Assay for Early-Stage Lung Cancer Recurrence Risk
    A Fox Chase Cancer Center study will evaluate a tumor-informed, whole-genome sequencing–based test to assess recurrence risk in early-stage NSCLC.
    onclive · 3mo ago↗ source
  • EGFR-Mutated NSCLC: Mechanism and Clinical Role of TROP2-Directed ADCs
    In this segment, Dr. Sands asks the panel to discuss the emerging role of TROP2-directed antibody–drug conjugates in EGFR-mutated non-small cell lung cancer. Dr. Wakelee and Dr. Cooper explain that…
    onclive · 3mo ago↗ source
  • Dr Parikh on the Feasibility and Importance of Immunotherapy Trials in Anal Cancer
    Aparna R. Parikh, MD, discusses how trials like PODIUM-303 are reshaping the treatment paradigm for squamous cell anal carcinomas.
    onclive · 3mo ago↗ source
  • EGFR-Mutated NSCLC: Targeting MET-Driven Resistance in Second-Line Therapy
    In this segment, Dr. Sands asks Dr. Wakelee to discuss how emerging data on MET-driven resistance mechanisms are shaping second-line treatment decisions in EGFR-mutated non-small cell lung cancer.
    onclive · 3mo ago↗ source
  • Sequencing ADCs in Endometrial Cancer
    Sequencing therapy in recurrent endometrial cancer is becoming more complicated as immunotherapy moves earlier and antibody drug conjugates gain momentum.
    onclive · 3mo ago↗ source
  • Dr Silbermann on Clinical Trial Design Considerations in Multiple Myeloma
    Rebecca Silbermann, MD, MMS, outlines key trial design considerations in multiple myeloma, including supportive care measures and end point selection.
    onclive · 3mo ago↗ source
  • MimiVax and Roswell Park Open Phase 2 Trial of SurVaxM for Patients with Metastatic Neuroendocrine Tumors
    Roswell Park Comprehensive Cancer Center launched a phase 2 trial evaluating SurVaxM plus temozolomide in progressing neuroendocrine tumors.
    onclive · 3mo ago↗ source