Recent And Upcoming FDA Advisory Committee Meetings
Executive Summary
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
You may also be interested in...
FDA Seems Set To Label Eylea For Retinopathy Of Prematurity Despite Failed Primary Endpoint
Two studies failed to demonstrate that Eylea was non-inferior to laser treatment. Agency says compared to the expected natural history, there is a ‘clear beneficial effect’ of Eylea which also maintains peripheral vision. Advisory committee to discuss how to convey findings in label.
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.