Manufacturing issues prompt FDA to reject Hengrui-Elevar filings for third time
An inspection of a facility making Elevar’s rivoceranib uncovered deficiencies, leading the FDA to reject a combination therapy that includes the drug. The rebuff is the third strike for the partners after the agency issued manufacturing-related denials for the other drug in the combo.
Manufacturing issues prompt FDA to reject Hengrui-Elevar filings for third time Read More »
