Posted by Michael Wonder on 19 Feb 2024
VivaGel BV US FDA appeal outcome
19 February 2024 - Starpharma today announces that it has completed the formal dispute resolution process with the US FDA in relation to VivaGel BV.
The FDA has maintained its position that they require additional clinical efficacy data to be generated for the regulatory approval of VivaGel BV for bacterial vaginosis in the US.
