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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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.
Further progress for Daiichi Sankyo's strategic push into oncology as US issues first approval globally for first-in-class rare disease drug Turalio - but with liver toxicity safeguards.