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BLA submitted: Q1 2027 Standard review reaches PDUFA date: Q1Q2 2028 Complete Response Letter issued instead of approval Additional data requested and resubmitted: 618 months Approval: Late 2028 or 2029 Launch: Early-to-mid 2029 After BLA Submission: The FDA Review Process Month 02: Filing Decision (60 Days) The FDA reviews the application for completeness
Hormonal health HRT linked to greater weight loss on tirzepatide Postmenopausal women on hormone replacement therapy lost 35 per cent more weight while taking tirzepatide, a new study suggests
Elife 7 , e34408 (2018)
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