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U.S. Food and Drug Administration Approves Addition of Positive Data from Phase 3 VALOR-HCM Study to CAMZYOS (mavacamten) Label

16.06.2023 - Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) to add positive data from the Phase 3 VALOR-HCM study to the U.S. Prescribing Information for ...
Anjalit Owens Bristol Myers Squibb York Heart Association Bristol Myers Squibb Company Exchange Commission Journal Of The American College Cardiology

Clinical Overview and Clinical Summary Training Course: Creating Effective Marketing Authorisation Applications - Regulatory Guidelines and Requirements of Module 2 (February 8-9, 2023)

/PRNewswire/ -- The "Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application Training Course" conference has been added...
United States John Price Laura Wood Alexion Pharmaceuticals Office Hours Call Medicines Control Agency

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