News

RC18 Receives FDA’s Fast Track Designation for Treating SLE

The U.S. Food and Drug Administration (FDA) has granted fast track designation to RemeGen‘s RC18 (telitacicept) to treat people with systemic lupus erythematosus (SLE). A therapy candidate is put on the FDA’s fast track program if it can treat serious conditions and fill an unmet clinical need, either because no…

RemeGen Raises $100M to Advance Potential Lupus Treatment, RC18

RemeGen has received $100 million in private financing to continue advancing RC18 (telitacicept), its lead treatment candidate for autoimmune diseases like systemic lupus erythematosus (SLE) now in a pivotal clinical trial. The funding will also support the China-based company’s early stage treatment discovery platform, help expand its manufacturing…

Voclosporin for Lupus Nephritis Under ‘Rolling’ Review by FDA

Aurinia Pharmaceuticals announced the start of a rolling submission of its application requesting that voclosporin be approved in the U.S. to treat people with lupus nephritis. In a rolling submission, completed portions of a New Drug Application (NDA) are submitted for review by the U.S. Food and Drug Administration…