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
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 resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer
Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity
GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization
The EMBOLD study evaluated relutrigine for patients with SCN2A and SCN8A developmental and epileptic encephalopathies
Here's a new ray of hope for new hope for patients suffering from Meniere’s disease (MD) and sensorineural hearing loss
HER2-mutant NSCLC typically has a poor prognosis and limited treatment options
The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study
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