Pfizer and biontech initiate rolling submission of biologics license application for u.s. fda approval of their covid-19 vaccine

New york and mainz, germany, may 7, 2021 (globe newswire) — pfizer inc. (nyse: pfe) and biontech se (nasdaq: bntx) today announced the initiation of a biologics license application (bla) with the u.s. food and drug administration (fda) for approval of their mrna vaccine to prevent covid-19 in individuals 16 years of age and older. data to support the bla will be submitted by the companies to the fda on a rolling basis over the coming weeks, with a request for priority review. the prescription drug user fee act (pdufa) goal date for a decision by the fda will be set once the bla is complete and formally accepted for review by the agency.
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