Keeping Track: Incyte’s Opzelura Earns First Vitiligo Claim; NDAs From Apellis, Acadia
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
You may also be interested in...
An analyst had suggested that in the event of a thumbs-down from the FDA, the company could end up focusing on other catalysts instead.
Celltrion has secured a US launch date for its higher-strength adalimumab biosimilar, Yuflyma, through a settlement with AbbVie. However, the company will face a number of other Humira rivals in 2023.
Six of the 10 biosimilar candidates under FDA review are waiting on inspections delayed by COVID-19; in the meantime, sponsors jockey for position when Humira biosimilar launch windows open up next year.