Tag Archive for: withdrawn approval

The U.S. Food and Drug Administration (FDA) on Thursday withdrew its approval for Covis Pharma’s preterm birth prevention drug, Makena, saying that the drug was not effective in treating the complication.

A federal judge in Texas could soon order the U.S. Food and Drug Administration to withdraw its approval of abortion pill mifepristone, a move that if allowed to stand could severely undermine the agency, health policy and legal experts said.

As the FDA cracks down on accelerated approvals, Genentech, a Roche company, voluntarily withdrew its monoclonal antibody Tecentriq (atezolizumab) for a specific type of previously untreated metastatic bladder cancer.  

The U.S. Food and Drug Administration said on Wednesday it has withdrawn the health regulator’s approval for TG Therapeutics Inc.’s lymphatic cancer treatment Ukoniq over concerns of higher risk of death in patients receiving the drug.