FDA Approves First Gene Therapy for Severe Leukocyte Adhesion Deficiency Type I
For Immediate Release: March 26, 2026 The U.S. Food and Drug Administration today approved Kresladi (marnetegragene autotemcel), the first gene therapy for the treatment of severe Leukocyte Adhesion Deficiency Type I (LAD-I). Kresladi is indicated for the treatment of...CASGEVY
STN: 125787Proper Name: exagamglogene autotemcel (exa-cel)Tradename: CASGEVYManufacturer: Vertex Pharmaceuticals IncorporatedIndication:STN 125787 – Treatment of sickle cell disease (SCD) and the treatment of transfusion dependent β-thalassemia (TDT) in patients...FY 2025 GDUFA Science and Research Report
What is the GDUFA Science & Research Program?The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) continually advances scientific understanding through research to ensure the safety, effectiveness, and quality of drugs in the...Cryoprobe Recall: Erbe USA Removes Flexible Cryoprobes
The affected products have been updated to remove a part number with no affected lots. The recommendations for what to do with the devices below have not changed. This recall involves removing certain devices from where they are used or sold. The FDA...All Drug Purchases Are
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