DATA GRAPHICS | Data Byte
2023 ties record for FDA approvals with companion diagnostics
Last year matched 2018’s record for FDA product approvals accompanied by pharmacogenomic tests
January 16, 2024 10:47 PM UTC
A year-over-year analysis shows the number of new drugs approved with companion diagnostics is growing, with FDA approving five such pairings in 2023, tying the record set in 2018.
Although the agency first approved a drug and companion diagnostic pairing in 1998, such approvals were rare until 2011, with their number increasing after the agency issued the first guidance on co-development in 2014. Since 2015, at least two new products have been approved with a test each year...