An FDA rejection letter for Corcept Therapeutics’ potential hormonal disorder drug says the agency told the company it had serious concerns before the application was

Bitterroot Bio, a biotech from leading minds in the CD47 field, appears to have returned to the discovery stage after attempting to expand the potential

EU regulators have refused to greenlight Eli Lilly’s weight loss drug Mounjaro as a treatment for a type of heart failure, while giving the go-ahead

Ultragenyx has resubmitted its approval request for a rare disease gene therapy after the FDA rejected it last summer. UX111 is an AAV gene therapy

Quince Therapeutics’ once-monthly steroid-based treatment failed a Phase 3 trial for a rare genetic condition called ataxia-telangiectasia, prompting the Bay Area company to say it