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LEVERKUSEN (dpa-AFX) - Bayer (BYR.L, BAY.MI, BAYN.DE) announced the FDA has accepted the supplemental New Drug Application and granted Priority Review designation for Lynkuet under investigation for the treatment of moderate to severe vasomotor symptoms in women receiving endocrine therapy for trea…
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
Today Bayer announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review designation for Lynkuet® (elinzanetant) under investigation for the treatment of moderate to severe vasomotor symptoms (VMS, also kn…
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.