Posted by Michael Wonder on 21 Feb 2022
Allarity Therapeutics receives refusal to file letters from U.S. FDA
18 February 2022 - Allarity intends to seek guidance from the FDA on how to further advance dovitinib and its accompanying DRP dovitinib companion diagnostic towards approval.
Allarity Therapeutics today announced that the U.S. FDA has provided the Company with refusal to file letters regarding the new drug application for dovitinib, and its accompanying pre-market approval application for the DRP Dovitinib companion diagnostic, for the third-line treatment of metastatic renal cell carcinoma.
