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Dynavax Down 5% on FDA Complete Response Letter for Heplisav-B for Hemodialysis
UPDATE 1-US FDA Declines to Approve Expanded Use of Dynavax's Hepatitis B Vaccine
Dynavax Application for Hepatitis B Treatment Ruled Insufficient by FDA
By Denny Jacob Dynavax disclosed that the Food and Drug Administration has ruled its application for its hepatitis B vaccine treatment didn't provide sufficient data to support the full evaluation of
Express News | Shares of Dynavax Down 7.9% Premarket After FDA Declines Expanded Use of Its Hepatitis B Vaccine in Dialysis Patients
Express News | FDA Issued Complete Response Letter To Dynavax Saying SBLA For Four-Dose HEPLISAV-B Regimen Did Not Provide Sufficient Data To Support Full Evaluation Of Effectiveness Or Safety
Express News | Dynavax Technologies:Crl Does Not Affect Approval From European Commission in Oct 2023 for 4-Dose Heplisav-B Regimen for Adult Hemodialysis Population