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FDA news in pediatrics: June 2025
01 Jul 2025 20:03 GMT
… treatments without medication side effects.
On June 9, 2025, the FDA … phase 3 SMART trials, which demonstrated that … the CLEVER trial, clesrovimab reduced medically attended lower … (KalVista Pharmaceuticals), an investigational oral treatment for hereditary …
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FDA Approves Benlysta Autoinjector for Pediatric Patients With Active Lupus Nephritis
01 Jul 2025 02:29 GMT
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FDA Approves Benlysta Autoinjector for Pediatric Patients With Active Lupus Nephritis
30 Jun 2025 22:37 GMT
… Food and Drug Administration has approved an autoinjector of Benlysta (belimumab … adverse reactions seen with Benlysta were serious infections, … . "Having the Benlysta autoinjector provides a much … frequent clinic visits for treatment and add greater …
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GSK (GSK) Gains FDA Approval for Benlysta Autoinjector for Lupus Treatment
28 Jun 2025 16:50 GMT
… GSK) Gains FDA Approval for Benlysta Autoinjector for Lupus Treatment A pharmacist … gastrointestinal drugs. Benlysta autoinjector is the first-of-its-kind treatment option … researches, develops, and sells medicines and vaccines for infectious diseases, HIV, …
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FDA Approves Benlysta Autoinjector for Pediatric Lupus Nephritis
27 Jun 2025 16:55 GMT
… the U.S. Food and Drug Administration (FDA) has approved a 200 … aggressive and severe. Having the Benlysta autoinjector provides a much-needed … receive an effective treatment at home, easing their treatment journey.”
Caregivers of …
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FDA Approves At-Home Belimumab Injection for Children with Lupus Nephritis
26 Jun 2025 01:16 GMT
… home treatment option with the efficacy and safety of Benlysta is … healthcare provider will administer treatment or the healthcare provider … them to administer the medicine at home via an … The US FDA first approved Benlysta for the treatment of active SLE …
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US FDA approves GSK’s Benlysta autoinjector for lupus nephritis
25 Jun 2025 16:25 GMT
The US Food and Drug Administration (FDA) has approved GSK’s … home treatment option with the efficacy and safety of Benlysta is … received its initial FDA approval as a treatment option for … open for the prestigious Pharmaceutical Technology Excellence Awards - …
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FDA Approves Belimumab Autoinjection for Patients 5 and Older With Active Lupus Nephritis
25 Jun 2025 01:42 GMT
… cure for lupus nephritis, but treatment can include steroids, cyclosporine, … older could only receive the medication through an intravenous formulation … for our free Drug Topics newsletter.
REFERENCES
1. FDA approves Benlysta (belimumab) Autoinjector …
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FDA Approves At-Home Belimumab Autoinjector for Pediatric Lupus Nephritis
24 Jun 2025 23:45 GMT
… in lupus pathogenesis. The drug was first approved to … treatment option with the efficacy and safety of Benlysta … with findings from adult trials, according to the release … available immediately.
References
FDA approves benlysta (belimumab) autoinjector for …
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FDA approves at-home belimumab autoinjector for children with lupus nephritis
24 Jun 2025 16:26 GMT
The US Food and Drug Administration (FDA) has approved a 200 mg … -home treatment option with the efficacy and safety of Benlysta is … Live vaccines should not be given within 30 days of treatment, … reactions reported in clinical trials with pediatric and adult …