AstraZeneca, FibroGen's roxadustat hits snag at FDA, but analysts figure an approval's still on its way

Submitted by admin on December 21, 2020 - 11:46pm

Source:

Fierce Pharma

News Tags:

AstraZeneca

FibroGen

roxadustat

FDA

anemia

Headline:

AstraZeneca, FibroGen's roxadustat hits snag at FDA, but analysts figure an approval's still on its way

snippet:

Partners AstraZeneca and FibroGen had been hoping for a 2020 approval for their blockbuster-to-be anemia drug roxadustat in the U.S., but that's not going to happen.

The FDA pushed its decision deadline to March 20—from December 20—to review “further clarifying analyses of clinical data," AstraZeneca said Friday. The companies say they plan to submit the analyses as soon as possible.

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AstraZeneca, FibroGen's roxadustat hits snag at FDA, but analysts figure an approval's still on its way

AstraZeneca, FibroGen's roxadustat hits snag at FDA, but analysts figure an approval's still on its way