WASHINGTON (AP) — The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to ...
Regenxbio (RGNX) shares fell after the U.S. Food and Drug Administration issued a complete response letter for RGX-121 ...
Pharmaceutical Technology on MSN
REGENXBIO receives FDA response for RGX-121 application
REGENXBIO plans to request a Type A meeting with the FDA to discuss the CRL and its planned BLA resubmission.
FDA open to pooling data from ongoing Phase I/II studies of LX2006 with data from pivotal trial, and to earlier co-primary endpoint assessment, to support a Biologics License Application FDA approved ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results