Eledon Pharmaceuticals’ lead asset, tegoprubart, is going to late-stage trials in kidney transplant rejection prevention, despite missing its primary efficacy endpoint. In the Phase II BESTOW trial ...

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The U.S. Food and Drug Administration is starting to publish letters the agency sent to pharmaceutical companies when their drugs were rejected, detailing information that until now has mostly been ...

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided an in-depth view into the high-stakes discussions that decide whether a medicine will ever make ...

Sanofi SNY announced that the FDA has granted orphan drug designation to its investigational drug, riliprubart, for the treatment of antibody-mediated rejection (AMR) in solid organ transplantation.