QIDP Designations
Executive Summary
Qualified Infectious Disease Product Designations granted by FDA. Updated upon new designations.
You may also be interested in...
Rx For Industry: Key Provisions Of The 21st Century Cures Act
Changes to the priority review voucher program, economic communications with payors, and approval of antimicrobial products all have the potential to impact the commercial prospects of drugmakers.
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.