News | January 09, 2026
Oculis’ Privosegtor wins FDA breakthrough therapy status for Optic Neuritis
The FDA designation follows visual-function results from the Phase 2 ACUITY trial
The FDA designation follows visual-function results from the Phase 2 ACUITY trial
This product has only one approved generic and one authorized generic with an addressable market share of US$ 172 million
Receiving Orphan Drug Designation is an important milestone in the clinical development of CK0804 for myelofibrosis
Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations
The investigational subcutaneous hepcidin mimetic peptide is designed to regulate iron and red blood cell production
The MAGiC catheter is designed for robotically-navigated cardiac ablation procedures
The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety
Currently approved for patients eight and older, Tzield could now be used to delay the onset of stage 3 type 1 diabetes (T1D) in children diagnosed with stage 2 T1D
The company said it received notice on January 1 from the FDA’s Center for Veterinary Medicine that the funding will support its ongoing effectiveness study of Canalevia-CA1
The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence
Subscribe To Our Newsletter & Stay Updated
