Media round-up about the FDA taking major steps to advance the implementation of real-time clinical trials. Paradigm Health CEO, Kent Thoelke, via press release: “This collaboration represents an important step toward expediting how clinical trial data is submitted to and reviewed by the FDA…With Paradigm Health's platform, clinical trial data can be analyzed for key signals in near real time and shared with trial sponsors and the FDA in days, rather than months. This means that regulators, sponsors, and providers can have a continuous view of safety and efficacy. By modernizing the flow of information from sites to sponsors to regulators, we have an opportunity to accelerate the delivery of innovative therapies to patients across the country.” Triatomic Capital Co-Founder, Jeff Huber, via X: “Huge progress from the @US_FDA, to enable innovation with speed and quality with 'real-time clinical trials.' Many thanks to @JonathanHirsch & the Paradigm Health Team for helping show the way!” · InVitria Founder and CEO, Scott E. Deeter, via X: “This is smart!” · Tevogen Bio Founder and CEO, Ryan Saadi, via X: “Brilliant! Faster development of life-saving therapies, Improved patient affordability & U.S. Derya Unutmaz, M.D., via X: “This is a very big deal! Incredible to see this acceleration in clinical trials happening thanks to the amazing leadership at @US_FDA! Accelerating clinical trials via AI is a key milestone toward my bold claim that we can treat/cure most, or even all, diseases within a decade!” Matt Ripkey, healthcare technologist and investor via X: “This is fantastic progress! Clinical trials is a market that, implemented effectively, will dramatically improve public perception of AI. It shouldn't take 8-12 years to bring treatments to market.

Original title: “WTAS: FDA Announces Major Steps to Implement Real-Time Clinical Trials | HHS.gov”

Catch up on any of the neurology headlines you may have missed in January 2026, compiled into 1 place by the NeurologyLive® team. The coverage includes the latest FDA approvals, new designations, submissions, resubmissions, and clinical trial initiations and holds. Click the read more buttons for more details and information about each update. On January 5, 2026, the FDA approved ScinoPharm Taiwan’s glatiramer acetate (GA) injection as a treatment for relapsing multiple sclerosis (MS), making it the first complex injectable generic approval for this therapy.1 That guidance allows waiving traditional clinical bioequivalence trials if the generic demonstrates tight structural and compositional matching, as well as in vitro and in vivo functional similarity. On January 6, 2026, the FDA granted breakthrough therapy designation to Alkermes’ alixorexton, an investigational oral, selective orexin 2 receptor agonist, for the treatment of narcolepsy type 1 (NT1), using positive phase 1 and phase 2 data, including the phase 2 VIBRANCE-1 trial (NCT06358950), to support the decision. Months after the FDA issued a complete response letter (CRL) to the new drug application (NDA) for Sentynl Therapeutics’ copper histidinate, on January 12, 2026, the agency approved the agent as the first treatment for pediatric patients with Menkes disease, a rare genetic neurodegenerative disorder.3 Marketed as Zycubo, the therapy is a subcutaneous copper replacement treatment that delivers copper in a form designed to bypass impaired intestinal absorption and support systemic utilization of the mineral. "This milestone represents the culmination of decades of research into better understanding and ultimately finding an effective treatment for Menkes disease," Stephen Kaler, MD, a clinical genetics and genomics specialist, and professor of pediatrics at the Columbia University Medical Center, said in a statement.3 "Increased awareness of Menkes disease and rapid testing upon suspicion are critical, as beginning copper histidinate therapy in affected neonates has been shown to reduce symptoms and prolong life."

Original title: “FDA Action Update, January 2026: Approvals, Acceptance, and Clearance | NeurologyLive - Clinical Neurology News and Neurology Expert Insights”