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IntroductionThe U.S. Food and Drug Administration (FDA) has recently approved a ground-breaking gene therapy for the treatment of Aromatic L-amino Acid Decarboxylase (AADC) deficiency, marking a significant advancement in the field of genetic disorders. This approval is a beacon of […]
The USFDA’s 2024 regulatory changes At Vigilare Biopharma, we understand the complexities and challenges that pharmaceutical companies face when navigating the ever-evolving regulatory landscape. The USFDA’s 2024 regulatory changes reflect a significant shift towards enhancing drug safety, efficacy, and accessibility. […]
