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 submitted.
The complete response letter, released …
Welcome back to Endpoints Weekly! Fourth-quarter earnings season is in full swing, and our team covered reports this week from Teva, Roche, Sanofi, Takeda and
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
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 submitted.
The complete response letter, released …