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Name | Symbol | Market | Type |
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AstraZeneca PLC | NYSE:AZN | NYSE | Depository Receipt |
Price Change | % Change | Price | High Price | Low Price | Open Price | Traded | Last Trade | |
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0.00 | 0.00% | 54.17 | 0 | 01:00:00 |
By Colin Kellaher
AstraZeneca PLC (AZN, AZN.LN) and Merck & Co. (MRK) on Tuesday said the U.S. Food and Drug Administration accepted and granted priority review to a supplemental new-drug application for Lynparza in a form of prostate cancer.
The drugmakers said the filing covers the treatment of patients with metastatic castration-resistant prostate cancer and deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutations, who have progressed following prior treatment with a new hormonal agent.
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.
AstraZeneca and Merck, which in 2017 formed a collaboration to co-develop and co-commercialize AstraZeneca's Lynparza for multiple cancer types, said the agency has set a target action date for the second quarter.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
January 21, 2020 07:28 ET (12:28 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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