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 Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care
The funding will support the pivotal Phase 3 clinical trial of neridronate in CRPS-1
Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo
Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo
For patients with resectable early-stage gastric and gastroesophageal junction cancers
Enhertu has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung and gastric cancers
The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age
Boehringer Ingelheim plans to study this novel investigational therapy in patients with progressive fibrosing interstitial lung diseases
Gantenerumab is an investigational antibody in Phase III development for early Alzheimer's disease (AD) and a comprehensive data set with an expected readout in mid-2022
Subscribe To Our Newsletter & Stay Updated
