Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by ...
After a series of unfortunate regulatory rejections and manufacturing issues surfaced, Regeneron’s shares dipped to $483 this ...
The FDA issued a Complete Response Letter for Regeneron’s biologics license application for odronextamab, a bispecific antibody targeting CD20 and CD3 for the treatment of relapsed or refractory ...
The U.S. Food and Drug Administration (FDA) on Friday approved Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi SA’s (NASDAQ:SNY) Dupixent (dupilumab) for adult patients with bullous pemphigoid ...
The inaugural approval under the program has gone to USAntibiotics and its domestically manufactured extended-release ...
Regeneron Pharmaceuticals, Inc. REGN announced that the FDA has approved the label expansion of PD-1 inhibitor Libtayo (cemiplimab-rwlc). Libtayo is now approved as an adjuvant treatment for adult ...