Merck, AstraZeneca Receive FDA Extension on Lynparza New Drug Application Date
December 15 2022 - 07:30AM
Dow Jones News
By Denny Jacob
Drugmaker Merck & Co. and pharmaceutical company AstraZeneca
PLC on Thursday said the Food and Drug Administration will extend
the date for lynparza's pending supplement new drug
application.
The companies said the extension is to provide more time to
fully review the submission.
The application is for lynparza in combination with abiraterone
and prednisone or prednisolone as a treatment for adults with
metastatic castration-resistant prostate cancer, Merck and
AstraZeneca said.
Write to Denny Jacob at denny.jacob@wsj.com
(END) Dow Jones Newswires
December 15, 2022 07:15 ET (12:15 GMT)
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