EMA accepts filing for Heplisav (Dynavax Technologies), a vaccine for Hepatitis B. - 23-Aug-2012
The EMA has accepted the filing of the Marketing Authorization Application for Heplisav vaccine, from Dynavax Technologies, pursuing an indication for immunization against infection caused by all known subtypes of Hepatitis B virus in adults 18 through 70 years of age and in patients with chronic kidney disease. Acceptance of the MAA confirms that the submission is sufficiently complete to permit a substantive review by the EMA. The FDA accepted for review the biologics license application (BLA) for the drug in June 2012.
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