US Food and Drug Administration (FDA)

Neurons
#AC Immune #Immunotherapy #Neuroscience #Parkinson's #US Food and Drug Administration (FDA)

Immunotherapy for Parkinson’s gets FDA Fast Track Designation

AC Immune has received Fast Track designation and clearance of its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) for its anti-alpha-synuclein (a-syn) active immunotherapy candidate, ACI-7104, for the treatment of early-stage Parkinson’s disease (PD).  ACI-7104 is designed to induce… Read More

#Editor's Choice #News #Regulatory

#Cardiomyopathy #Drug development #Drug discovery #FDA #HAYA Therapeutics #nHCM #RNA therapy #Symptomatic nonobstructive hypertrophic cardiomyopathy (nHCM) #US Food and Drug Administration (FDA)

Treatment underway for nonobstructive hypertrophic cardiomyopathy 

The US Food and Drug Administration (FDA) has granted Fast Track Designation for HAYA Therapeutics’ HTX-001 for the treatment of symptomatic nonobstructive hypertrophic cardiomyopathy (nHCM).   The first-in-class investigational long non-coding RNA (lncRNA)-targeting therapy is in a Phase Ia/b trial, with the first cohort dosed this past May.  HTX-001 is a… Read More

#News