AbbVie’s ADC has secured FDA clearance for an ultra-rare blood cancer while the agency has delayed its decision on ...

The FDA has delayed a decision on the approval of AstraZeneca’s camizestrant, deferring its ruling to review analyses filed ...

May 27 (Reuters) - AstraZeneca said on Wednesday the U.S. Food and Drug Administration has extended the decision deadline for ...

AstraZeneca (AZN) announced on Wednesday that the U.S. Food and Drug Administration has delayed a review of its marketing ...

AstraZeneca and Daiichi Sankyo have secured approval from the US Food and Drug Administration (FDA) for Datroway (datopotamab ...

The review extension comes weeks after an advisory panel found the evidence supporting the drug, camizestrant, inconclusive ...

AstraZeneca said the U.S. FDA has extended the decision date for its camizestrant new drug application, which seeks approval of the oral SERD in combination with CDK4/6 inhibitors as a first-line ...

AstraZeneca AZN announced that the FDA will extend the Prescription Drug User Fee Act (PDUFA) date for reviewing the new drug application (NDA) seeking approval of camizestrant in combination with a ...

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.

FDA grants Priority Review to AstraZeneca’s Imfinzi sBLA for muscle-invasive bladder cancer, with decision expected in Q2 2025. Imfinzi regimen showed a 32% reduced risk of disease progression and a ...