Baudax Bio, Inc.

Companies that are developing local anesthetic products intended to have a long-acting effect should collect trial data on “clinically meaningful outcomes,” such as reduction in hospitalization, even

A rare sponsor victory on an appeal of a complete response letter for Ardelyx Inc. ’s phosphate absorption inhibitor Xphozah (tenapanor) could embolden other sponsors to pursue dispute resolution whe

Axsome Therapeutics, Inc. , New York, NY, has become the latest sponsor entranced by the analgesic potential of meloxicam to stumble on the BCS class II drug’s virtual insolubility. Like others before

Ardelyx Inc. is preparing to join the small group of sponsors challenging US FDA complete response letters through the formal dispute resolution process – a process that sees more appeals denied than