Regulation
FDA approves AstraZeneca's Etcamah for ctDNA-guided breast cancer treatment
The FDA granted accelerated approval to AstraZeneca's camizestrant (Etcamah) for HR-positive, HER2-negative breast cancer patients with an ESR1 mutation.
#Accelerated approval and confirmatory trials
Every Medical Research story tagged Accelerated approval and confirmatory trials.
Regulation
FDA Grants Accelerated Approval to AstraZeneca's Etcamah
The FDA has granted accelerated approval to AstraZeneca's Etcamah for HR-positive, HER2-negative advanced breast cancer with ESR1 mutations.
Regulation
UniQure Seeks FDA Approval for Huntington's Gene Therapy
UniQure has submitted AMT-130, a gene therapy for Huntington's disease, to the FDA for accelerated approval based on three-year data showing it can slow disease progression.