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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208443

FDA
16 Jan 2024

https://www.businesswire.com/news/home/20211207005586/en

BUSINESSWIRE
07 Dec 2021

https://www.businesswire.com/news/home/20201012005201/en

BUSINESSWIRE
12 Oct 2020

https://www.astellas.com/en/corporate/news/detail/astellas-submits-application-f.html

ASTELLAS
31 Jul 2017

http://www.pmlive.com/pharma_news/after_delay,_merck_gets_us_approval_for_serious_infection_drug_1174395

Phil Taylor PMLIVE
25 Oct 2016