Posted by Michael Wonder on 28 Mar 2019
Drug makers continue to clamour for FDA approval of orphan drugs
28 March 2019 - Orphan drugs may serve small groups of patients, but they generate big numbers at the Food and Drug Administration.
Last year, the agency issued a record-breaking 91 orphan drug approvals, up from 81 approvals in 2017 and well above levels seen in previous years. We should point out, though, that approvals include not only new drugs, but also applications for new orphan uses of previously approved medicines, otherwise known as repurposed drugs.
