Keeping Track: Approvals For Mayzent, Mavenclad, Duaklir, Jatenzo And Cimzia
The latest drug development news and highlights from our US FDA Performance Tracker.
You may also be interested in...
Roche Paying $390m Up Front For Fibrosis-Fighting Promedior
The deal, which includes up to $1bn for milestones, gives Roche Promedior’s PRM-151, a Phase III-ready asset for IPF that has also completed a Phase II study in myelofibrosis and could be effective in a broad range of fibrotic diseases.
Lilly's Taltz Approved For AS As New Guidelines Keep TNF Inhibitors In Front Line
VP Rebecca Morison said the ankylosing spondylitis indication adds more evidence of Taltz's benefits. She noted Lilly believes there should be fewer steps before AS patients access IL-17 inhibitors.
CMC Review Update: Evenity Sequence Variants, Sunosi Split-Tablet Risks, Mayzent Particle Size
Redacted drug approval packages highlight key issues in US FDA quality reviews of Amgen’s Evenity, Jazz’s Sunosi and Novartis’ Mayzent.