Merck Gets FDA Priority Review of Vaxneuvance Vaccine in Children
2021年12月1日 - 9:36PM
Dow Jones News
By Colin Kellaher
Merck & Co. on Wednesday said the U.S. Food and Drug
Administration granted priority review to its application for
expanded use of its Vaxneuvance 15-valent vaccine in children six
weeks through 17 years of age.
The Kenilworth, N.J., drugmaker in July received FDA approval of
the vaccine for the prevention of invasive pneumococcal disease in
adults.
The FDA grants priority review to medicines that have the
potential to provide significant improvements in the treatment of a
serious disease, and the designation shortens the review
period.
Merck said the agency set a target action date of April 1, 2022,
for its application.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
December 01, 2021 07:21 ET (12:21 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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