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EMA

3 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Oculis Holding Ag

Oculis Gains European Fast-Track Status for Optic Neuritis Drug Privosegtor

Oculis secures EMA PRIME fast-track designation for Privosegtor, a potential first-in-class neuroprotective optic neuritis therapy, following FDA Breakthrough status in January 2026.
OCSOCSAWclinical trialsrare disease
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Oculis Scores EMA PRIME Designation for Optic Neuritis Drug Privosegtor

Oculis' neuroprotective candidate Privosegtor receives EMA PRIME designation for optic neuritis, following FDA Breakthrough designation and positive Phase 2 data.
OCSOCSAWrare diseaseorphan drug
BenzingaBenzinga··Business Wire

Savara Clears FDA Hurdle for MOLBREEVI as Drug Advances Toward Autoimmune PAP Approval

Savara receives FDA Day 74 Letter for MOLBREEVI with no advisory committee meeting planned. PDUFA target date set for August 2026.
SVRAFDA approvalMOLBREEVI