UPDATE 1-AstraZeneca's combo lung disease therapy fails to win FDA approval [Yahoo! Finance News]
AstraZeneca PLC Ordinary Shares (AZN)
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Source: Yahoo! Finance News
The U.S. Food and Drug Administration declined to approve AstraZeneca Plc's combination therapy to treat smoker's lung, the drugmaker said on Tuesday. AstraZeneca said that it will work closely with the FDA regarding next steps, including submitting results from an additional late-stage study, which was not completed at the time the marketing application was submitted to the health regulator. The therapy, PT010, was approved in Japan in June as a triple-combination therapy to relieve symptoms of chronic obstructive pulmonary disease (COPD), AstraZeneca said.
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- 3/4/26 - Form CERT
- 3/3/26 - Form 8-A12B
- 3/2/26 - Form 6-K
- AZN's page on the SEC website