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
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.
The FDA has given approval to AveXis for the first treatment of paediatric spinal muscular atrophy (SMA).