The FDA will be launching an expanded access pilot dubbed ‘Project Facilitate’ by End of May.  This program is aimed at improving patient access to unapproved oncology drugs: https://www.raps.org/news-and-articles/news-articles/2019/5/fda-to-launch-expanded-access-pilot-project-facil?feed=Regulatory-Focus The FDA has granted Breakthrough Therapy Designation for Sunovion’s schizophrenia drug: http://www.wbjournal.com/article/20190513/NEWS01/190519988 Celgene reported that the FDA has granted Breakthrough Therapy designation to POMALYST® (pomalidomide) for[…]