Will Dynavax Get FDA Nod For Label Expansion Of Hepatitis B Vaccine?

The company has sought FDA approval to expand the use of its hepatitis B
vaccine Heplisav-B for adults on hemodialysis and a decision is due on
May 13, 2024.

The Heplisav-B vaccine, which combines hepatitis B surface antigen with
Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist adjuvant CpG
1018, was approved by the FDA in November 2017, for prevention of
infection caused by all known subtypes of hepatitis B virus in adults of
age 18 years and older.

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by RTTNews Staff Writer

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