Tag: dose

REYKJAVIK, Iceland, June 08, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio^® (vedolizumab) lyophilized vial for intravenous administration.

Basel, June 8th, 2026 – Novartis will present data from 10 abstracts at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2026, spanning Rhapsido^®  (remibrutinib) clinical trial results and real-world evidence on patient burden and treatment experience. Highlights include two late-breaking oral presentations; the Phase III RemIND trial for Rhapsido in chronic inducible urticaria (CIndU) and extension data from the Phase IIIb REMIXED trial in chronic spontaneous urticaria (CSU).

“The Rhapsido presentations at EAACI 2026 expand our understanding of BTK inhibition across multiple immune-mediated diseases and provide evidence of its potential to make a meaningful impact for patients who continue to face significant burden and limited treatment options,” said Angelika Jahreis, Global Head, Immunology Development, Novartis. “Novartis will present Rhapsido data from a long-term extension trial in chronic spontaneous urticaria, Phase III data in three types of chronic inducible urticaria, and early Phase II dose-response analysis for food allergy – together providing scientific evidence for its impact across numerous diseases.”

Abstracts accepted by EAACI include: 

Ingelheim, Germany - Boehringer Ingelheim today announced positive results from two global Phase III trials of its glucagon/GLP-1 dual agonist survodutide (BI 456906), SYNCHRONIZE-1 and SYNCHRONIZE-MASLD.^2,4 The results demonstrate survodutide’s potential to reduce weight and therefore improve metabolic health in two distinct populations: adults living with obesity or overweight, without type 2 diabetes (SYNCHRONIZE-1),² and adults with overweight or obesity with metabolic dysfunction-associated steatotic liver disease (MASLD) with evidence of inflammation and or fibrosis (SYNCHRONIZE-MASLD).⁴ Full results from SYNCHRONIZE-1 and SYNCHRONIZE-MASLD were presented today at the American Diabetes Association’s (ADA) 2026 Scientific Sessions and published simultaneously in The New England Journal of Medicine and Nature Medicine respectively.^5,6