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Pfizer Inc said on Wednesday the U.S. Food and Drug Administration will review its respiratory syncytial virus (RSV) vaccine candidate on priority. It could become the first approved RSV vaccine in the U.S. for older adults who are at risk of the lung disease. Pfizer's application to the FDA is supported by data from a late-stage study in which the vaccine was found safe and effective.
NEW YORK, December 07, 2022--Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a Biologics License Application (BLA) for its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, as submitted for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.