FDA News

LONDON--(BUSINESS WIRE)--C2N Diagnostics, LLC ("C2N"), a pioneer in advanced diagnostic testing for brain health, and Cambridge Cognition, the neuroscience technology company, announce on World Alzheimer’s Day a partnership with The Alzheimer's Trust, a newly formed subsidiary of The Cancer Screening Trust, to address the urgent and growing burden of Alzheimer's disease and related dementias in the United Kingdom (UK).The collaboration creates an integrated, scalable pathway for earlier and more...

BOSTON--(BUSINESS WIRE)--PureTech Health plc (LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, today announced the successful completion of the End-of-Phase 1 (EOP1) meeting with the U.S. Food and Drug Administration (FDA) and the receipt of FDA Fast Track designation for LYT-200 in combination with a hypomethylating agent (HMA) for the treatment of relapsed/refractory (R/R) high-risk my...

LIESTAL, Switzerland--(BUSINESS WIRE)--Curatis Holding AG (SIX:CURN, “Curatis”) reports net sales from goods and services of CHF 7.9m for the first half of 2026, up 51% (H1 2025: CHF 5.2m), with the loss for the period narrowing to CHF -0.4m (H1 2025: CHF -1.2m) and cash and cash equivalents rising to CHF 3.6m (31 December 2025: CHF 1.9m). Curatis also advanced its corticorelin (C-PTBE-01) program on multiple levels, including an exclusive Japan licence with Neupharma and continued manufacturin...

AUSTIN, Texas--(BUSINESS WIRE)--IntraBio Inc., a leader in the discovery, development, and commercialization of novel therapies for rare and common neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved AQNEURSA® (levacetylleucine) for the treatment of ataxia in adult and pediatric patients with ataxia-telangiectasia (A-T) weighing ≥15 kg. AQNEURSA is the first and only drug approved for the treatment of A-T anywhere in the world. In the United...

ST. LOUIS--(BUSINESS WIRE)--The CEO and co-founder of C2N Diagnostics, LLC (“C2N”), a specialty diagnostics company with a vision to bring Clarity Through Innovation®, has accepted another honor on behalf of his team to cap a month-long series of significant achievements.The Nimoy-Knight Foundation, which celebrates “Star Trek” actor and director Leonard Nimoy's legacy of hope, inspiration, and compassion for all, chose Dr. Joel Braunstein for its Live Long & Prosper Tribute Award. The award...

BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma announces FDA acceptance of dersimelagon NDA with Priority Review and closes acquisition from Tanabe Pharma...

LYON, France--(BUSINESS WIRE)--MaaT Pharma Provides Update on MaaT013 (Xervyteg®) Potential Development Plan Following CHMP Negative Opinion After Re-examination...

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus” or the “Company”), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, today announced that the U.S. Food and Drug Administration’s (FDA) Cosmetics Regulatory Science Branch has licensed ADMET Predictor® to support its computational research for modern cosmetic safety assessment. The contract expands the use of Simulations Plus technology...

CAMBRIDGE, Mass. & MCCOMB, Miss.--(BUSINESS WIRE)--Royal Philips, a global leader in health technology and Southwest Mississippi Regional Medical Center (SMRMC), which serves as the hub of Southwest Health, today announced that the hospital has installed the first Philips Rembra CT system for acute and high-demand imaging environments in the United States. The new system is designed to support the McComb hospital’s high-demand emergency imaging environment with the goal of expanding local acces...

WESTON, Mass.--(BUSINESS WIRE)--Medical technology company Sempresto, developing a smartphone-integrated drug delivery platform designed to make rescue medications more readily available when needed, today announced a positive response to its Type B Pre-Investigational New Drug (Pre-IND) written submission to the U.S. Food and Drug Administration (FDA) regarding its investigational smartphone-integrated epinephrine auto-injector. Sempresto submitted a comprehensive briefing package containing a...