|
|
|
Company Name
|
Dynavax Technologies Corp
|
|
Drug Name
|
HEPLISAV (BLA)
|
|
Event Name
|
FDA panel to review HEPLISAV for hepatitis B virus in adults
|
|
Event Date
|
11/15/2012
|
|
Outcome
|
FDA panel voted 13 to 1 endorsing immunogenicity of HEPLISAV; But voted 8 to 5 there was insufficient data to adequately support its safety
|
|
Drug Status
|
|
|
Rival Drugs
|
|
|
Market Potential
|
|
|
Other Approvals
|
|
|
News |
|
|
|
Return to FDA Calendar
|