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Takeda's TAK-881 Meets Primary Endpoint in Phase 2/3 Trial for Primary Immunodeficiency Disease
NewsMay 4, 2026

Takeda's TAK-881 Meets Primary Endpoint in Phase 2/3 Trial for Primary Immunodeficiency Disease

Takeda announces positive topline results for TAK-881, showing pharmacokinetic comparability to HYQVIA in pivotal Phase 2/3 trial for PID patients.

Oliver Grant
BioCryst Secures $70M Upfront in European Licensing Deal for Navenibart Hereditary Angioedema Treatment
NewsMay 4, 2026

BioCryst Secures $70M Upfront in European Licensing Deal for Navenibart Hereditary Angioedema Treatment

BioCryst receives $70M upfront plus milestone payments up to $275M for navenibart licensing agreement with Neopharmed Gentili's Irish affiliate in Europe.

Charlotte Meyer
SetPoint Medical Begins Multiple Sclerosis Trial for Setpoint System Neuroimmune Therapy
NewsMay 1, 2026

SetPoint Medical Begins Multiple Sclerosis Trial for Setpoint System Neuroimmune Therapy

SetPoint Medical enrolls first patients in pilot study testing Setpoint System for relapsing-remitting multiple sclerosis treatment with FDA approval.

Sofia Alvarez
HUTCHMED's Sovleplenib Receives Priority Review and Breakthrough Designation in China for Rare Blood Disorder
NewsHematology/Immunology - Autoimmune Hemolytic AnemiaApr 30, 2026

HUTCHMED's Sovleplenib Receives Priority Review and Breakthrough Designation in China for Rare Blood Disorder

HUTCHMED announces NDA acceptance with priority review status for sovleplenib to treat warm antibody autoimmune hemolytic anemia in China.

Charlotte Meyer
Norgine Receives European Approval for XOLREMDI (Mavorixafor), First WHIM Syndrome Treatment in EU
NewsApr 29, 2026

Norgine Receives European Approval for XOLREMDI (Mavorixafor), First WHIM Syndrome Treatment in EU

Norgine's XOLREMDI becomes the first authorized treatment for WHIM syndrome in Europe, marking a breakthrough for ultra-rare immunodeficiency patients.

Prof. Marcus Webb
Norgine Receives European Commission Approval for XOLREMDI (Mavorixafor) as First WHIM Syndrome Treatment
NewsPrimary Immunodeficiency - WHIM SyndromeApr 29, 2026

Norgine Receives European Commission Approval for XOLREMDI (Mavorixafor) as First WHIM Syndrome Treatment

Norgine's XOLREMDI becomes first authorized treatment for WHIM syndrome in Europe, marking breakthrough for ultra-rare immunodeficiency patients.

Dr. Hannah O'Connor
EMA Establishes Expert Panel to Strengthen COVID-19 mRNA Vaccine Trust Including Spikevax and Comirnaty
NewsApr 29, 2026

EMA Establishes Expert Panel to Strengthen COVID-19 mRNA Vaccine Trust Including Spikevax and Comirnaty

European Medicines Agency forms international expert panel to enhance public confidence in COVID-19 mRNA vaccines including Spikevax and Comirnaty.

Dr. Hannah O'Connor
Artiva Biotherapeutics' AlloNK Receives FDA Fast Track Designation for Refractory Rheumatoid Arthritis Treatment
NewsApr 29, 2026

Artiva Biotherapeutics' AlloNK Receives FDA Fast Track Designation for Refractory Rheumatoid Arthritis Treatment

FDA grants Fast Track Designation to Artiva's AlloNK (AB-101) for refractory rheumatoid arthritis, accelerating development of innovative NK cell therapy.

Dr. Elena Rossi
Brii Bio's Elebsiran Shows Durable Hepatitis B Control in APASL 2026 Cross-Study Analysis
NewsApr 27, 2026

Brii Bio's Elebsiran Shows Durable Hepatitis B Control in APASL 2026 Cross-Study Analysis

Brii Bio's elebsiran combined with pegylated interferon demonstrates sustained HBsAg loss and favorable off-treatment outcomes in hepatitis B patients.

Sofia Alvarez
Repertoire Immune Medicines Doses First Patient in RPTR-1-201 Phase 1/2 Trial for Advanced Solid Tumors
NewsApr 23, 2026

Repertoire Immune Medicines Doses First Patient in RPTR-1-201 Phase 1/2 Trial for Advanced Solid Tumors

Repertoire Immune Medicines begins Phase 1/2 trial of RPTR-1-201, a novel TCR bispecific therapy targeting advanced solid tumors across US and European sites.

Charlotte Meyer
Abivax Presents Obefazimod Phase 3 Data at Digestive Disease Week 2026
NewsApr 23, 2026

Abivax Presents Obefazimod Phase 3 Data at Digestive Disease Week 2026

Abivax showcases comprehensive Phase 3 ABTECT program results for obefazimod in inflammatory bowel disease at DDW 2026 conference.

Charlotte Meyer
Roche's Gazyva Receives FDA Acceptance for Lupus Treatment Following Positive Phase III Trial Results
NewsApr 23, 2026

Roche's Gazyva Receives FDA Acceptance for Lupus Treatment Following Positive Phase III Trial Results

FDA accepts Roche's supplemental application for Gazyva (obinutuzumab) in systemic lupus erythematosus based on positive ALLEGORY study results.

Prof. Marcus Webb