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100 stories matching this filter · ← front page

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  • FDA approves first freeze-dried plasma product for U.S. use
    The FDA has licensed Ezplaz Freeze Dried Plasma (FDP), marking the first freeze-dried plasma product cleared for use in the United States. The product is intended for adult patients who need plasm…
    fda press · 1d agoApprovalPositive↗ source
  • Early Alert: Percutaneous Catheter Issue from Boston Scientific
    ENROUTE Transcarotid Neuroprotection Systems may have arterial sheath tip separation or partial tip separation during use
    fda medwatch · 7d ago↗ source
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Vaccines463
Endocrinology & Metabolism280
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Pain221
BAXTER ISSUES VOLUNTARY NATIONWIDE RECALL OF CEFAZOLIN IN DEXTROSE INJECTION, USP, 2G / 100ML (20MG / ML) SINGLE-DOSE INFUSION BAG IN 100ML DUE TO PARTICULATE MATTER FOUND IN SOLUTION
July 24, 2026 – DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily recalling Lot LD175708, Exp 14-Feb 2027 of Cefazolin in Dextrose Injection due to a report of particulate matter…
fda recalls · 7d ago↗ source
  • American Regent, Inc. Issues Voluntary Nationwide Recall of One Lot of Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL Due to the Presence of Visible Particulate Matter
    July 24, 2026 – Shirley, NY, American Regent, Inc. is conducting a nationwide voluntary recall of a single lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single dose vial to the consume…
    fda recalls · 7d ago↗ source
  • FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
    The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduc…
    fda press · 13d ago↗ source
  • Catheter Introducer Kit Recall: Abiomed Removes 14Fr Low Profile Introducer Kits
    Prolonged use of the Abiomed 14Fr Low Profile Introducer may lead to thrombus formation.
    fda medwatch · 14d ago↗ source
  • Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System
    Affected grafts may not unclasp from the delivery system. This may require conversion to open surgical repair and can result in patient death.
    fda medwatch · 14d ago↗ 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 · 22d 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 · 24d 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 · 24d 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 · 25d ago↗ source
  • FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease
    The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recu…
    fda press · 29d ago↗ source
  • FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients
    The U.S. Food and Drug Administration today approved TREGZI, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult pat…
    fda press · 1mo ago↗ source
  • FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing
    FDA announces the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufac…
    fda press · 1mo ago↗ source
  • FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes
    On June 12, 2026, the U.S. Food and Drug Administration granted accelerated approval to Tzield (teplizumab) for a new indication, to delay the decline of insulin production in pediatric patients ag…
    fda press · 1mo ago↗ source
  • FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children
    The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an in…
    fda press · 1mo ago↗ source
  • FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
    Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarr…
    fda press · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo ago↗ source