Do FDA Submission, Approval Declines Outside Cancer Signal Future Treatment Gaps?

Outlining a "fairly substantial decline in the number of non-oncology NMEs approved compared to last year" plus downward trend in applications, US FDA's Jenkins underscores continued "tremendous needs" for primary care products.

While oncology drug development continues to be fairly lively, a drop in FDA applications and approvals in other therapeutic areas may raise concerns about the longer-term outlook for treatment options.

Reviewing data on applications received and approved by the Center for Drug Evaluation and Research since 2013, Office of New...