Merck & Co Inc

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Merck Receives Complete Response Letter From US FDA For Supplemental Biologics License Application For Keytruda In High-Risk Early-Stage Triple-Negative Breast Cancer

Published: 03/29/2021 21:48 GMT
Merck & Co Inc (MRK) - Merck Receives Complete Response Letter From US FDA for Supplemental Biologics License Application (sbla) for Keytruda® (pembrolizumab) in High-risk Early-stage Triple-negative Breast Cancer (tnbc).
Merck & Co Inc - Merck is Reviewing Letter and Will Discuss Next Steps With FDA.
Merck & Co - FDA's Oncologic Drugs Committee Voted 10-0 That Regulatory Decision Should Be Deferred Until Further Data is Available From Keynote-522.
Merck & Co Inc - Crl Does Not Impact Any Current Approved Indications for Keytruda.