The FDA has delayed a decision on the approval of AstraZeneca’s camizestrant, deferring its ruling to review analyses filed ...
DNA-PK inhibitor compounds have potential in solid tumors and blood cancers. The AstraZeneca subsidiary, KuDOS Pharmaceuticals, exercised its option to license exclusive rights to a DNA-dependent ...
US FDA extends PDUFA date and seeks additional data from AstraZeneca’s NDA for camizestrant in combo with a CDK 4/6 inhibitor to treat HR-positive, HER2-negative advanced breast ...
AstraZeneca PLC on Wednesday said that the US Food & Drug Administration has extended the review period for its camizestrant filing to allow time for the assessment of additional data related to the ...
May 2026Camizestrant in combination with a CDK4/6 inhibitor recommended for approval in the EU by CHMP for 1st-line advanced ER-positive breast cancer Recommendation based on SERENA-6 Phase III trial ...
May 2026 US FDA decision date extended for SERENA-6 filing of camizestrant to enable review of additional data The US Food and Drug Administration (FDA) has informed AstraZeneca that it will extend ...
AstraZeneca's camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) has been ...
The recommendation, based on data from the SERENA-6 trial, breaks from the opinion of an FDA advisory committee last month.
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