The FDA’s approval covers use of Venclexta (venetoclax) in combination with azacytidine, or decitabine, or low-dose cytarabine (LDAC) for newly diagnosed AML in adults 75 years or older ...

The FDA has made it clear that the primary bar for NTM drug approval is patient ... seek FDA input on our selection of QOL-B as the new primary efficacy endpoint prior to unblinding the Phase ...

Achieving this important milestone of receiving our first country's approval puts us another step ... and potential additional feedback from the FDA and their foreign equivalents, utilizes an ...

Earlier this year, the United States Department of Health and Human Services Office of the Inspector General (HHS OIG) ...

The FDA has ... for NTM drug approval is patient-reported improvement in NTM symptoms. Our recent statistical analysis plan submission provides the opportunity to seek FDA input on our selection of ...