i2O Therapeutics, Inc.

The US Food and Drug Administration appears to have closed the door to further debate on the approvability of Intarcia Therapeutics ’s ITCA 650, an exenatide implant for type 2 diabetes. The drug-dev

Vanda Pharmaceuticals, Inc. is escalating its struggle with the US Food and Drug Administration over complete response letters for new indications for its sleep disorder drug Hetlioz (tasimelteon) th

Intarcia Therapeutics, Inc. is continuing its battle with the Center for Drug Evaluation and Research claiming that the unanimous advisory committee vote against its ITCA 650 drug-device combo for tr

The battle between Intarcia Therapeutics, Inc. and the US Food and Drug Administration’s Center for Drug Evaluation and Research over the safety and effectiveness of the ITCA 650 drug-device implant