The trial also revealed statistically significant and clinically meaningful gains in key patient-reported outcomes
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
Developed using STEERLife’s proprietary FragMelt continuous processing platform, the approval marks a major breakthrough in pharmaceutical manufacturing
Preclinical studies show that 4P004 modulates multiple biological markers across the joint, potentially slowing structural damage while improving function
CTx001 targets Geographic Atrophy (GA) secondary to Age-related Macular Degeneration
MH002, a rationally designed live microbial consortium, combines six well-characterized commensal strains to target disease-specific mechanisms
Vanda strongly disputes the FDA’s reasoning
The FDA designation follows visual-function results from the Phase 2 ACUITY trial
The approval is backed by data showing deep, durable responses and manageable tolerability
Receiving Orphan Drug Designation is an important milestone in the clinical development of CK0804 for myelofibrosis
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