Keeping Track: FDA OKs AMAG's Vyleesi, But Bronchitol And Quizartinib Draw CRLs
The latest drug development news and highlights from our US FDA Performance Tracker.
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Astellas' Phase III Front-Line AML Study Of Xospata Fails
One expert said the company should focus efforts on developing the drug for maintenance treatment of AML.
Keeping Track: Chiesi Breathes Easier With Bronchitol Approval; Submissions Aplenty From GSK, Pfizer, AZ, AbbVie
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
AMAG’s Vyleesi Review Offers Lessons On Impact Of Patient Input
US FDA accepted change in Phase III endpoint hierarchy for the hypoactive sexual desire disorder drug based on input from a patient-focused drug development meeting and scientific workshop; bremelanotide review documents advise on use of multiple anchor scales to help interpret meaningfulness of changes in clinical outcome assessment scores.