Regeneron Pharmaceuticals (NASDAQ:REGN) said on Thursday that the U.S. FDA will be reviewing the supplemental biologics license application ((sBLA)) for Eylea HD injection, 8 mg, to treat macular ...

Schleifer attributed the shift to more patients using off-label bevacizumab ... information over to the FDA posthaste following the rejection, Schleifer said. Eylea HD is already approved ...

which is the maximum dosing interval currently indicated in the label). Regeneron is evaluating the FDA’s decision and will determine a path forward in due course. EYLEA HD is approved with ...

The FDA disagreed with Regeneron ... dosing interval on the currently approved label. Regeneron has not yet responded to the letter. Currently, EYLEA HD is approved for dosing intervals of ...

said on Thursday that the U.S. FDA will be reviewing a supplemental biologics license application ((sBLA)) for its eye disease drug Eylea HD injection, 8 mg, to expand its label and to broaden its ...