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The FDA more quickly granted regular approval to drugs that had confirmatory ... and delayed completions should be a cautionary sign for patients and oncologists considering prescribing these ...
Thousands of Americans campaigning for the Novavax COVID-19 booster got some good news this week: the FDA signaled it might ...
At FDA, full vaccine approval is the gold standard. The agency was on track to sign off on Novavax’s license by its April 1 target date, according to two people with direct knowledge of the ...
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The vaccine maker said it believes commitments to run new trials would be after it receives approval for the shot. Sign up here. "Based on what we've received to date, formally from FDA ...
The FDA extended aficamten's review by three months for REMS safety program finalization, causing Cytokinetics' stock to drop ...