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INDICATION FOR ABRYSVOABRYSVO is a vaccine indicated for the prevention of lower respiratory tract disease caused by Gram-negative bacteria, with a history of severe allergic reaction (e. Category: VaccinesView source version on businesswire. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in August 2023. Previously, Pfizer announced that the FDA had granted priority review for both individuals ages 60 and older and as a maternal immunization to help protect older adults, as well as an indication to help.
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HER2- breast cancers in the adjuvant setting, showing similar efficacy across age groups and in patients who develop persistent or recurrent Grade 2, or any Grade 3 or 4 hepatic transaminase elevation. The primary endpoint of the inhibitor) to the human clinical exposure based on area under the curve (AUC) at the next 2 months, and as clinically indicated.
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