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Jazz Pharmaceuticals Announces U.S. FDA Approval of Modeyso™ (dordaviprone) as the First and Only Treatment for Recurrent H3 K27M-mutant Diffuse Midline Glioma

Modeyso is the first treatment option for this ultra-rare and aggressive brain tumor, which primarily affects children and young adults Accelerated approval based on an...

Donanemab receives positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in early symptomatic Alzheimer’s disease

The opinion will now be referred to the European Commission for final regulatory decision on donanemab  INDIANAPOLIS, July 25, 2025 /PRNewswire/ -- Eli Lilly and...

IMAAVY™ (nipocalimab-aahu) showed greater sustained disease control versus approved FcRn blockers for generalized myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly...

The ITC compared all published Phase 3 data of these treatments, leveraging longitudinal results, and findings reinforce the importance of consistent, sustained disease control...

Neurocrine Biosciences Presents New Data Showing Significant Patient-Reported Improvements in Health-Related Quality of Life with INGREZZA® (valbenazine) Capsules in Older Adults with Tardive Dyskinesia

Data Add to Growing Body of Evidence Demonstrating Functional and Quality of Life Improvements in Patients Treated with INGREZZA for Tardive Dyskinesia Findings Presented at...

Dupixent® (dupilumab) Approved in the U.S. as the Only Targeted Medicine to Treat Patients with Bullous Pemphigoid (BP)

Approval based on pivotal results showing improvements in sustained disease remission and reductions in itch and oral corticosteroid use compared to placebo in adults with BP

Dupixent® (dupilumab) Demonstrated Superiority Over Xolair® (Omalizumab) in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) in Patients with Coexisting Asthma in First-ever Presented Phase 4...

New late-breaking data at EAACI showed Dupixent outperformed Xolair across all primary and secondary efficacy endpoints of CRSwNP and in all asthma-related endpoints

Celldex Presents Data Demonstrating Profound Long Term Improvement in Angioedema in Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EAACI 2025

HAMPTON, N.J., June 14, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced data demonstrating that barzolvolimab profoundly improves angioedema at 52 weeks in the Company’s Phase 2 clinical trial in chronic spontaneous urticaria (CSU). Angioedema, characterized by swelling of the deeper dermal layers of the skin and mucous membranes, is a painful, debilitating symptom of CSU that has significant impact on quality of life. It commonly affects the face (lips and eyelids), hands, feet, and genitalia but can also involve the tongue, uvula, soft palate, and pharynx1.

Celldex Presents Unprecedented 76 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EAACI Congress 2025

HAMPTON, N.J., June 12, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today new data demonstrating profound, sustained complete response and improved quality of life at 76 weeks, 7 months after the completion of dosing with barzolvolimab in chronic spontaneous urticaria (CSU), an immune-related condition driven by mast cell activation. Barzolvolimab specifically targets mast cells by binding the receptor tyrosine kinase KIT with high specificity and potently inhibiting its activity, which is required for mast cell function and survival.

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