The FDA accepts for priority review Regeneron's (REGN) sBLA for Evkeeza for treating children aged five to 11 years with homozygous familial hypercholesterolemia. A decision is due on Mar 30, 2023.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new and updated data across its oncology pipeline will be presented at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2022 from December 7 to 9 in Geneva, Switzerland. Presentation highlights include first clinical results and new exploratory analyses from trials investigating LAG-3 inhibitor fianlimab and/or PD-1 inhibitor Libtayo® (cemiplimab) in non-small cell lung cancer (NSCLC), melanoma and cervica
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Evkeeza® (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 years with homozygous familial hypercholesterolemia (HoFH). The FDA target action date is March 30, 2023.