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News 2026-09-28 12:01 UTC

Bayer: U.S. FDA Accepts sNDA, Grants Priority Review to Lynkuet as New Indication for Treatment of Moderate to Severe Vasomotor Symptoms Due to Endocrine Therapy Related to Breast Cancer >BAYN.XE

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News 2026-09-28 12:00 UTC

Bayer says FDA accepts Lynkuet sNDA, grants priority review

The U.S. FDA accepted Bayer’s supplemental New Drug Application for Lynkuet and granted Priority Review for a new indication in women receiving endocrine therapy for breast cancer. The filing is based on Phase III OASIS-4 data.

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Bayer: U.S. FDA Accepts sNDA, Grants Priority Review to Lynkuet as New Indication for Treatment of Moderate to Severe Vasomotor Symptoms Due to Endocrine Therapy Related to Breast Cancer >BAYN.XE

Bayer says FDA accepts Lynkuet sNDA, grants priority review