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New harmonised guidance for post-approval changes released by FDA
The FDA has published its finalised guidance for drug lifecycle management, including an improved framework for the management of post-approval changes.
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Center for Biologics Evaluation and Research
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FDA allows Pfizer’s COVID-19 vaccine to be used in adolescents
The Comirnaty® vaccine’s emergency use authorisation has been extended to allow its administration to those 12 years of age and above in the US.
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FDA approves first gene therapy for paediatric spinal muscular atrophy
The FDA has given approval to AveXis for the first treatment of paediatric spinal muscular atrophy (SMA).
