With a decision by FDA on a new filing for flibanserin possible by the fall, Sprout hopes to gain the first U.S. approval for treating women with low sexual desire. Meanwhile, Palatin forges on to Phase III with its female sexual desire disorder drug bremelanotide after discussing endpoints with FDA.
If successful, a resubmitted filing of flibanserin by Sprout Pharmaceuticals Inc. could provide a roadmap for drug development in female sexual dysfunction, a field that up to now has been marred by regulatory failures.
Flibanserin is an agonist of serotonin 5HT(1A) and an antagonist of 5-HT(2A) receptors. It is also a partial agonist of...
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
The group had been laid off as part of the 1 April reduction-in-force, which led to missed guidance publication deadlines.
US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.
Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.
It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.
