Crl

Regeneron’s pre-filled syringe for eye injection finally approved by FDA

20-Aug-2019 By Maggie Lynch

Regeneron receives FDA approval on its Eylea pre-filled syringe injection after a CRL last year requesting additional data.

FDA observes manipulation of data at Immunomedics facility

14-Feb-2019 By Ben Hargreaves

Following the US FDA issuing a CRL to Immunomedics, the agency has revealed its inspection found instances of data integrity breaches and manipulation.

US FDA vetoes Regeneron’s Eylea syringe in CRL

30-Oct-2018 By Flora Southey

The US FDA has rejected Regeneron Pharmaceuticals’ prior-approval supplement for Elyea pre-filled syringe, requesting additional clinical data and manufacturing information.