EU Approval Delay for Janssen’s Spravato?
Third-Party Intervention Raises EU Approval Timing Question
The EMA has received written interventions from third parties relating to its CHMP opinion that the controversial antidepressant should receive EU approval.
You may also be interested in...
Concerns that written interventions might delay the expected EU approval of the novel ketamine-based antidepressant have come to naught.
Axsome is set to file for approval in the second half of 2020.
Drug companies in the EU explain how a new pilot scheme on national-level scientific advice service can benefit drug developers.