FDA issues CRL to PharmaTher’s ketamine ANDA
The CRL, dated 22 October 2024, comes ahead of the Generic Drug User Fee Amendments of 2022 (GDUFA) goal date set for 29 October 2024. Ketamine, an essential
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Sanofi and Regeneron’s Dupixent (dupilumab) in the European Union (EU) for paediatric patients with chronic spontaneous urticaria (CSU).
The acquisition bolsters AscellaHealth’s capabilities to serve international manufacturers and patients in more than 70 countries across the EU, Asia, Africa, Australia and the Americas. CHAPPER healthcare is