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AstraZeneca said the U.S. Food and Drug Administration is pushing back its decision on whether to approve a new breast-cancer drug.
The FDA delayed its decision on AstraZeneca's breast-cancer drug camizestrant to review new data.
KEY POINTS
AstraZeneca submitted additional analyses including longer-term efficacy outcomes for camizestrant.
Camizestrant previously received a negative vote from the FDA's advisory committee last month.
The European Medicines Agency's committee issued a positive opinion on camizestrant last Friday.
By Adria Calatayud
AstraZeneca said the U.S. Food and Drug Administration is pushing back its decision on whether to approve a new breast-cancer drug in order to review additional data provided by the company.
The U.K. drugmaker said Wednesday that it provided additional analyses requested by the FDA in support of its application for the drug candidate, camizestrant, after the regulator's drugs advisory committee voted against its approval late last month.
The new information provided by the company included data linked to longer-term efficacy outcomes that will be presented at a medical conference next week, AstraZeneca said.
The European Medicines Agency said Friday that its committee for medicinal products for human use issued a positive opinion on camizestrant.
Write to Adria Calatayud at [email protected]
(END) Dow Jones Newswires
05-27-26 0237ET