The EMA (European Medicines Agency) Committee for Medicinal Products for Human Use (CHMP) has published the highlights from their recently held September meeting.
At this meeting, there were 13 recommendations for approvals of medicines, of which one was an orphan medicine for the treatment of ovarian cancer.
The CHMP also published the findings from their re-examinations of three negative recommendations adopted at the May 2017 meeting; in all 3 cases the CHMP confirmed their initial refusals of these marketing authorisations.
The CHMP gave positive opinions of the extensions for 4 therapeutic indication, and a negative opinion on one application.
For a meeting summary, and the full list of approvals, opinions and withdrawals, please click here.