Final guidance on regulatory pathway for antibacterial and antifungal drugs is not substantially different from 2018 draft version but gives more detail on the process for submitting promotional materials prior to dissemination and seeking termination of LPAD labeling limitations.

Citing difficulties in conducting randomized trials, industry speakers call for a new way of thinking about the US FDA's substantial evidence standard for antifungal approvals under the LPAD route, as well as revisions to enrollment criteria and study endpoints.

The latest breakthrough therapy designation announcements from the Pink Sheet’s US FDA Performance Tracker

GlaxoSmithKline's first-of-its kind treatment for multiple myeloma is among 11 new medicines that have won an EU approval nod from the European Medicines Agency this week.