Tag Archive for: supplemental Biologics License Application (sBLA)

The FDA has approved Pfizer’s Prevnar 20 (20-valent Pneumococcal Conjugate Vaccine) for use in infants and children from six weeks to 17 years of age, the company announced Thursday.

Japanese drugmaker Eisai Co. Ltd. and its U.S. partner Biogen Inc. said on Monday that the U.S. Food and Drug Administration granted priority review for traditional approval of their Alzheimer’s treatment lecanemab.

Tuesday morning saw the FDA acceptance of a supplemental New Drug Application (sNDA) and supplemental Biologics License Application (sBLA) for three industry powerhouses. 

Merck scored another big win Wednesday with a U.S. Food and Drug Administration approval for an expanded indication of Vaxneuvance, its pneumococcal 15-valent conjugate vaccine. The new indication includes children 6 weeks through 17 years of age.

The U.S. Food and Drug Administration has a handful of PDUFA dates over the next two weeks.