Withdrawn Application Archives

Agenus Withdraws BLA for PD-1 Inhibitor

Biologics License Application (BLA), Blockbusters, Checkpoint Inhibitors, FDA/Regulatory, Merck, PD-1/PD-L1 inhibitors, Therapeutics, Withdrawn Application

Lexington, Mass.-based Agenus withdrew the company’s Biologics License Application (BLA) for the PD-1 inhibitor balstilimab from the U.S. Food and Drug Administration.

Ipsen Voluntarily Withdraws NDA Filing for FOP Drug

Business, FDA, Fibrodysplasia Ossificans Progressiva (FOP), New Drug Applications, Priority Review, Retinoic-acid receptor gamma agonist, Ultra Rare Diseases, Withdrawn Application

After discussions with the U.S. Food and Drug Administration, Paris-based Ipsen withdrew the company’s New Drug Application (NDA) for palovarotene.

Bristol-Myers Squibb Withdraws European Application of Opdivo Plus Yervoy for First-Line Treatment of Advanced NSCLC

Blockbusters, Checkpoint Inhibitors, Committee for Medicinal Products for Human Use (CHMP), European Commission, FDA, FDA/Regulatory, PD-1/PD-L1 inhibitors, Priority Review, Withdrawn Application

Bristol-Myers Squibb withdrew the company’s application in the European Union for the combination of Opdivo and Yervoy for the treatment of advanced non-small cell lung cancer (NSCLC) based on data from CheckMate -227.