New Drug Activity in 2017 In CY 2017 so far*, CDER has approved 40 NMEs, including 17 orphan drugs Record number of orphan indications approved across all NDAs and BLAs (not just NMEs and...

In 2017, 18 of CDER’s 46 novel drugs (39%) were approved to treat rare or “orphan” diseases that afect 200,000 or fewer Americans. Patients with rare diseases often have few or no drugs available to …

Jan 19, 2018 · Instead, newly approved CDER drugs are increasingly follow-on candidates in established drug classes. As in previous years, there is a continued focus on orphan indications and …

Jan 1, 2018 · Nearly two-thirds were approved under one or more accelerated pathways and just over one-third were designated as orphan drugs. Given the return to record-level FDA approvals, it is not …

In 2017, 18 of CDER’s 46 novel drugs (39%) were approved to treat rare or "orphan" diseases that affect 200,000 or fewer Americans. Patients with rare diseases often have few or no drugs available to …

Jul 16, 2025 · Annual number of new drugs approved by the US Center for Drug Evaluation and Research that fall under each designation, including Orphan Drugs, Fast Track, Accelerated …

Many of these products contain active moieties that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide …

This report provides a summary of the drug approvals by FDA's Center for Drug Evaluation and Research (CDER) in 2017, highlighting both novel drugs and other significant therapeutic advances.

The U. S. Food and Drug Administration released Advancing Health through Innovation: New Drug Therapy Approvals of 2017, a summary of the Center for Drug Evaluation and Research’s (CDER’s) …

Jan 10, 2018 · Similar to the first-in-class numbers, in 2017, 18 of CDER’s 46 novel drugs (39%) were approved to treat rare or “orphan” diseases that affect 200,000 or fewer Americans, whereas in 2016 …