A Guide for Initiating and Managing Chimeric Antigen Receptor T Cell Therapy Clinical Trials in Autoimmune Rheumatic Diseases. [PDF]
Chimeric antigen receptor (CAR) T‐cell therapy, long transformative in oncology, is now rapidly emerging as a frontier in autoimmune rheumatic diseases, particularly systemic lupus erythematosus (SLE), driven by accumulating evidence of deep B‐cell depletion, immune “resetting,” and durable drug‐free remission in early studies, yet its translation into
Caricchio R +11 more
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Efficacy and safety of iron-chelation therapy with deferoxamine, deferiprone, and deferasirox for the treatment of iron-loaded patients with nontransfusion-dependent thalassemia syndromes [PDF]
Cappellini, MD +4 more
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Safety and effectiveness of stiripentol in patients with Dravet syndrome: A prospective, 3-year, postmarketing surveillance study. [PDF]
Kitamura Y +6 more
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Postmarketing safety of migraine prophylactic monoclonal antibodies: An EudraVigilance database analysis of eptinezumab, fremanezumab, galcanezumab, and erenumab. [PDF]
Nikitina V +3 more
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Emerging Isseus in FDA Regulation: Warning Letters, Internet Promotion, and Tobacco [PDF]
Senger, Jeffrey M.
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Safety of the Selective JAK1 Inhibitor Oclacitinib in Dogs. [PDF]
Nederveld SM, Krautmann MJ, Mitchell J.
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WHO preferred product characteristics for bivalent Salmonella Typhi/Paratyphi A vaccine for comprehensive protection against enteric fever- key considerations and research gaps. [PDF]
Ibarz Pavon AB +13 more
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Discrepancies in regulations in post-marketing safety surveillance of drug-device combination products in the EU and US: a review. [PDF]
D'souza J, Nandave M, Blöchlinger R.
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Re-emergence of COVID-19 and preparedness.
Choudhary G, Rajput H, Medhi B.
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Hyaluronic Acid Hybrid Cooperative Complexes Nearing 10 Years of Use: Update on Safety Assessment Based on Post-Marketing Surveillance Data. [PDF]
Salti G +8 more
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