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Results For "autoimmune"

127 News Found

FDA grants priority review to Tzield for youngest Type 1 diabetes patients
Drug Approval | January 07, 2026

FDA grants priority review to Tzield for youngest Type 1 diabetes patients

Currently approved for patients eight and older, Tzield could now be used to delay the onset of stage 3 type 1 diabetes (T1D) in children diagnosed with stage 2 T1D


Savara resubmits FDA application for potential treatment in rare lung disease patients
Biopharma | January 01, 2026

Savara resubmits FDA application for potential treatment in rare lung disease patients

The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer


InnoCare Pharma gets green light for Phase II trial of oral lupus drug
Clinical Trials | December 27, 2025

InnoCare Pharma gets green light for Phase II trial of oral lupus drug

CLE, a common form of lupus erythematosus, primarily causes diverse skin lesions


EU nod to Wayrilz as breakthrough treatment for hard-to-treat ITP
Drug Approval | December 27, 2025

EU nod to Wayrilz as breakthrough treatment for hard-to-treat ITP

Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation


FDA nod to Boehringer Ingelheim’s JASCAYD for progressive pulmonary fibrosis in adults
Drug Approval | December 24, 2025

FDA nod to Boehringer Ingelheim’s JASCAYD for progressive pulmonary fibrosis in adults

The study found that nerandomilast effectively slowed lung function decline in patients, with discontinuation rates similar to placebo


Asahi Kasei Pharma to move R&D hub to Shonan iPark in 2027
News | December 24, 2025

Asahi Kasei Pharma to move R&D hub to Shonan iPark in 2027

Shonan iPark was chosen for its globally connected life-science ecosystem, which unites pharmaceutical firms, next-generation medicine developers, AI and digital health innovators, venture capital, and academia


Qihan Biotech launches first-in-human trial of off-the-shelf CAR-T therapy for refractory lupus
Clinical Trials | December 21, 2025

Qihan Biotech launches first-in-human trial of off-the-shelf CAR-T therapy for refractory lupus

The study is being conducted under a USFDA IND, has received U.S. Fast Track Designation for SLE-ITP, and has obtained IND approval from China’s Center for Drug Evaluation


GenSci, RTW & Yarrow Bioscience strike $1.365 billion global deal for breakthrough graves’ disease therapy
News | December 19, 2025

GenSci, RTW & Yarrow Bioscience strike $1.365 billion global deal for breakthrough graves’ disease therapy

GS-098, a first-in-class, humanized monoclonal antibody targeting the thyroid-stimulating hormone receptor, is designed to rapidly block the pathogenic activity of thyroid-stimulating autoantibodies


AstraZeneca wins EU nod for self-administered lupus drug Saphnelo
News | December 17, 2025

AstraZeneca wins EU nod for self-administered lupus drug Saphnelo

Convenient subcutaneous option has potential to reach more patients with same clinical benefits as Saphnelo IV infusion


Zenas BioPharma and InnoCare hit key milestone in Lupus drug trial, secures China Phase 3 nod
Clinical Trials | December 16, 2025

Zenas BioPharma and InnoCare hit key milestone in Lupus drug trial, secures China Phase 3 nod

The study also showed a clear dose-dependent trend, with the 75 mg QD group outperforming the 50 mg QD cohort