Shenaz Bagha

The FDA has cleared an investigational new drug application for an unmodified neural-derived exosome to treat those with acute ischemic stroke, according to its manufacturer.In a press release, Aruna Bio Inc. said the FDA’s decision will allow its lead program, AB126, which can cross the blood-brain barrier, to be examined in a pending phase 1b/2a study that is expected to begin during the

The FDA has granted breakthrough therapy designation to latozinemab, an investigational therapeutic designed to block sortilin and elevate progranulin to treat frontotemporal dementia with a progranulin gene mutation.According to a press release from Alector Inc., the breakthrough designation was approved based on data from the phase 2 INFRONT-2 clinical trial of latozinemab in patients with the

The first subject has been dosed in a phase 1 clinical trial of an oral proteolysis-targeting chimera protein degrader to treat neurodegenerative diseases, according to the manufacturer.According to a release from Arvinas, ARV-102 was shown to cross the blood-brain barrier and degrade leucine-rich repeat kinase 2 (LRRK2) in preclinical studies. This property was crucial to efficacy as increased

The FDA has granted orphan drug designation to Cabaletta Bio’s CAR T-cell investigational therapy for the treatment of systemic sclerosis, according to a press release from the manufacturer. The drug, currently known as CABA-201, is a 4-1BB-containing, fully human CD19-CAR T cell, Cabaletta said in the release. According to the company, a clinical trial program including four phase 1/2

The monoclonal antibody Uplizna met key endpoints in a phase 3 trial for the treatment of IgG4-related disease, marking the first time a placebo-controlled study has shown benefit in the condition, according to a press release from Amgen.Topline results from the double-blind, randomized trial, called MITIGATE, demonstrated an 87% reduced risk for IgG4-related disease (IgG4-RD) flare in patients

The FDA has approved the Stelara biosimilar Pyzchiva for psoriatic arthritis, Crohn’s disease and all other indications approved for the reference medicine, according to a press release from Sandoz. Pyzchiva (ustekinumab-ttwe; Samsung Bioepis, Sandoz) is slated to debut on the U.S. marketplace in February, according to the release. The Stelara (ustekinumab, Janssen) biosimilar, which has

NYU Langone was again the top hospital in the United States for neurology and neurosurgery, according to the latest annual Best Hospitals Survey issued by U.S. News & World Report.The New York City-based health system topped the 2024-2025 national listing for the third consecutive year, based on its performance in treating conditions such as Alzheimer’s disease, Parkinson’s

Zevra Therapeutics has announced that Miplyffa, the first Nieman-Pick disease type C treatment approved by the FDA, is commercially available.Miplyffa (arimoclomol) is recommended for usage in tandem with miglustat to address symptoms related to the neurodegenerative lysosomal storage disorder for patients aged 2 years and older, the company said in a press release.

Exposure to various air pollutants, such as PM2.5 and nitrogen oxides, increases the risk for several autoimmune diseases, including psoriasis, lupus and rheumatoid arthritis, according to data published in Scientific Reports. “Although a large number of studies have shown that air pollution is strongly associated with the risk of [autoimmune diseases], there are often contradictions

The manufacturer of AV-101, an investigational, oral nonopioid, NMDA-targeting therapy to treat neuropathic pain, announced that it has received a U.S. patent for the treatment. AV-101 (4-Cl-KYN) is an oral prodrug that targets an ionotropic glutamate receptor in the brain, Vistagen said in a press release. Unlike other NMDA receptor antagonists such as ketamine and amantadine, AV-101’s