Centessa Pharmaceuticals reports encouraging clinical data for its oral OX2R agonist ORX750 in patients with narcolepsy Types 1 and 2 and idiopathic h...
FDA warns Liebel-Flarsheim in Raleigh, NC, about CGMP violations in its production of finished drugs.
FDA releases the form FDA-483 with four observations from an inspection at the Alembic Pharmaceuticals active pharmaceutical ingredient manufacturing ...
A STAT report highlighted in Medpage says CBER employees are concerned about the environment established by their new director, Vinay Prasad.
FDA issues Biohaven a complete response letter, rejecting the companys NDA for Vyglxia (troriluzole) as a treatment for spinocerebellar ataxia.
An Axios report following the resignation of CDER director George Tidmarsh questions how much more agency dysfunction industry can accept before simpl...
Sarepta Therapeutics reports mixed data from its Phase 3 ESSENCE confirmatory study evaluating its Duchenne muscular dystrophy drugs Amondys 45 (casim...
Compass Pathways says it expects to be able to launch its COMP360 psilocybin treatment for treatment-resistant depression nine to 12 months sooner tha...
