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 ...
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 ...
A new drug application (NDA) has been submitted to the FDA seeking approval of lirafugratinib (RLY-4008), a selective FGFR2 inhibitor, for second-line treatment of patients with cholangiocarcinoma ...
Reports positive pharmacokinetic (PK) results from the recently completed pediatric study for Anaphylm™ Completes submission of its New Drug Application (NDA) for Anaphylm to the FDA; NDA acceptance ...
Hosted on MSN
Achieve Life Sciences targets NDA submission for cytisinicline in June 2025 as open label study hits key milestones
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 ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results