The AURORA and BEACON studies demonstrated that bitopertin significantly reduces whole blood metal-free PPIX.

Applied Therapeutics announced yesterday its lead drug candidate's new drug application for approval to treat galactosemia had been rejected by the FDA. Govorestat had shown promising, but not quite ...

James V. Caruso, President and CEO, stated that Cellectar has made "significant strides across our development pipeline, regulatory strategy, corporate development initiatives and fundraising efforts, ...

PTC Therapeutics withdrew its New Drug Application (NDA) resubmission for Translarna (ataluren) in nonsense mutation Duchenne muscular dystrophy (nmDMD) following feedback from FDA indicating that the ...

CEO Rick Stewart stated that "Achieve is on track to submit the NDA for cytisinicline next month." He emphasized that "all internal resources are now focused on a successful NDA submission, acceptance ...