Insights+: The US FDA New Drug Approvals in August 2023

Shots: The US FDA approved 10 NDAs and 3 BLA in August 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 89 novel products in 2023 In August 2023, the major highlights drugs were Zurzuvae (zuranolone) approval for women with postpartum depression and Veopoz (pozelimab-bbfg) for children…

BySenior EditorSeptember 20, 2023

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Olivier Harari, VP, Early Clinical Development at Regeneron Shares his Views on Pozelimab’s BLA Acceptance for the US FDA Priority Review

Shots: Olivier highlighted the P-II/III data based on which Regeneron’s BLA for Pozelimab was accepted by the US FDA under priority review to treat adults and children with CHAPLE disease CHAPLE disease is driven by an overactivation of the complement system due to CD55 deficiency. Pozelimab blocks the activity of complement factor C5 and prevents…

BySenior EditorJuly 17, 2023

Olivier Harari, VP, Early Clinical Development at Regeneron Shares his Views on Pozelimab’s BLA Acceptance for the US FDA Priority Review

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Insights+: The US FDA New Drug Approvals in August 2023

Olivier Harari, VP, Early Clinical Development at Regeneron Shares his Views on Pozelimab’s BLA Acceptance for the US FDA Priority Review

FOLLW US

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