The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to privosegtor, an experimental treatment from Oculis that aims to protect the vision of people experiencing acute optic neuritis. This condition, which involves inflammation of the optic nerve, is a common and often debilitating symptom of…
Priority review
The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to Hope Biosciences‘ adipose-derived mesenchymal stem cells (HB-adMSCs) to treat relapsing-remitting multiple sclerosis (RRMS). RMAT status is given to therapies with compelling proof that they may substantially improve patient outcomes compared with existing…
Note: This story was updated April 4, 2025, to clarify the specific disability measures and that tolebrutinib is believed to target smoldering neuroinflammation. The U.S. Food and Drug Administration (FDA) has granted priority review to an application from Sanofi seeking the approval of its BTK inhibitor…
Tiziana Life Sciences has received fast track designation from the U.S. Food and Drug Administration (FDA) for its intranasal foralumab to treat nonactive secondary progressive multiple sclerosis (SPMS). The FDA gives fast track status to experimental medicines that have the potential to fill unmet needs to treat serious…
Tecfidera (dimethyl fumarate) was given the green light by health regulators in China to treat people with relapsing multiple sclerosis (MS) — clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. The National Medical Products Administration’s (NMPA) decision came through a priority review of clinical trial data for Tecfidera,…
The U.S. Food and Drug Administration (FDA) is giving priority review to a request to approve Ocrevus (ocrelizumab) as a treatment for both forms of multiple sclerosis, the drug’s developer, Genentech, announced. If the company’s Biologics License Application (BLA) is approved, Ocrevus will become the first drug able to treat patients with either relapsing or…
PathMaker Neurosystems Inc., a clinical-stage neuromodulation company focused on non-invasive therapies for neuromotor disorders, recently announced that the U.S. Food and Drug Administration (FDA) has granted the company’s MyoRegulator™ PM-2200 system the Expedited Access Pathway (EAP) designation and priority processing status. The MyoRegulator is the first product of PathMaker…