A comparison of EU approvals of medicines containing a new active substance in the first six months of 2021, 2022 and 2023 shows a sharp decline in the 2023 first-half numbers. Three of the products approved by the European Commission in the first six months of this year were for cancer, while two were for infectious diseases (including HIPRA’s COVID-19 vaccine Bimervax). Two products had orphan drug status.
The number of medicines containing a new active substance (NAS) authorized for marketing by the European Commission fell sharply in the first half of 2023, to just 11. This compares with a total of 27 NAS-containing products approved in the first half of 2022, and 28 in the same period of 2021.
The reasons for the decline in EU marketing authorizations up to the end of June are not clear – while...
Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.
Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
