On Biostatistics and Clinical Trials

After the NDA/BLA is submitted to FDA, the FDA review clock starts. There are several critical dates relevant to the applicant (the sponsor)...

Today, we learned that FDA declined to approve the emergency use authorization (EUA) for Veru's sabizabulin for the treatment of Covid. ...

In the previous article, the open-label extension (OLE) study was discussed. The OLE study is usually designed as a separate study from the ...

I asked OpenGPT to write a blog article about the open-label extension study and got the following response. The contents from OpenGPT seem ...