European Commission Approves Bristol Myers Squibb’s Sotyktu for Psoriatic Arthritis Following FDA Clearance
The European Commission (EC) granted marketing authorization this week for Bristol-Myers Squibb‘s (BMS, NYSE: BMY)...
Auto-immune
Mabwell Bioscience Secures FDA Clearance for 9MW5211 in IBD, Advances Multi-Indication Autoimmune Pipeline
Mabwell (Shanghai) Bioscience Co., Ltd. (SHA: 688062, HKG: 2493) announced it has received clinical clearance...
AbbVie Submits FDA Filing for Skyrizi Subcutaneous Induction Therapy in Crohn’s Disease – Expanding IL-23 Inhibitor Franchise
AbbVie (NYSE: ABBV) announced it has submitted a marketing approval filing to the U.S. Food...
AstraZeneca Secures FDA Approval for Subcutaneous Saphnelo in Systemic Lupus Erythematosus After Addressing Supplemental Data Request
AstraZeneca plc (NYSE: AZN) announced that the U.S. Food and Drug Administration (FDA) has approved...
Simcere Pharmaceutical Withdraws NDA for Rademikibart in Atopic Dermatitis, Plans Resubmission Later This Month
Simcere Pharmaceutical Group Limited (HKG: 2096) has withdrawn its New Drug Application (NDA) for rademikibart...
FDA Approves Sanofi-Regeneron’s Dupilumab for Pediatric Chronic Spontaneous Urticaria in Children Aged 2–11 Years
The U.S. Food and Drug Administration (FDA) has granted approval to Sanofi (NASDAQ: SNY) and...
AstraZeneca’s Ultomiris Shows Significant Proteinuria Reduction in Phase III IgA Nephropathy Trial
AstraZeneca plc (NYSE: AZN) announced positive results from a pre-specified interim analysis of the Phase...
Zelgen’s Jaktinib Hits Primary Endpoint in Phase III Atopic Dermatitis Trial – Dual JAK/ACVR1 Inhibitor Expands Beyond Myelofusion
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that its Phase III clinical trial evaluating...
Sanofi Secures EC Approval for Dupixent in Pediatric Chronic Spontaneous Urticaria – First Biologic Therapy for Children 2–11 Years
Sanofi SA (NASDAQ: SNY) announced that the European Commission (EC) has granted marketing authorization for...
AbbVie Secures NMPA Label Expansion for Rinvoq in China, Clarifying Use in UC and Crohn’s Disease
AbbVie Inc. (NYSE: ABBV) has announced that China’s National Medical Products Administration (NMPA) has approved...
Lynk Pharmaceuticals’ JAK1 Inhibitor Zemprocitinib Enters NMPA Review for Atopic Dermatitis
Lynk Pharmaceuticals Co., Ltd., a clinical-stage Chinese biopharmaceutical company, announced that the National Medical Products...
Rui Therapeutics Secures NMPA Approval for KN5501 CAR-NK Therapy in Autoimmune Diseases
Rui Therapeutics, a China-based cell therapy developer, announced it has received approval from the National...
Sanofi Secures EU Conditional Approval for Rezurock in Chronic Graft-Versus-Host Disease
Sanofi (NASDAQ: SNY) announced that the European Commission (EC) has granted conditional marketing authorization for...
J&J’s Icotyde Sustains and Improves Complete Skin Clearance in Psoriasis Through 52 Weeks, Outperforming Deucravacitinib on Safety
Johnson & Johnson (J&J, NYSE: JNJ) released 52-week long-term data from the Phase III ICONIC-ADVANCE...
Takeda’s Zasocitinib Demonstrates Superior Efficacy Over Apremilast and Placebo in Phase III Psoriasis Trials with Unprecedented TYK2 Selectivity
Takeda Pharmaceutical Company Limited (TYO: 4502, NYSE: TAK) reported positive top-line results from two pivotal...
Eli Lilly’s Taltz-Zepbound Combo Shows Superior Efficacy in Obese Psoriatic Arthritis Patients in Phase IIIb TOGETHER-PsA Trial
Eli Lilly and Company (NYSE: LLY) reported positive top-line results from the TOGETHER-PsA Phase IIIb...
Eli Lilly’s Lebrikizumab Demonstrates Four-Year Sustained Efficacy in Atopic Dermatitis, Reinforcing IL-13 as Core Therapeutic Target
Eli Lilly and Company (NYSE: LLY) reported new long-term data from an open-label extension study...
UCB’s Bimzelx Wins NMPA Approval for Two New Indications – IL-17A/F Dual-Target Antibody Expands into Psoriasis and Hidradenitis Suppurativa
UCB (EBR: UCB) announced National Medical Products Administration (NMPA) approval for Bimzelx (bimekizumab) in two...
Sanofi’s Dupixent Wins Japan Approval for Bullous Pemphigoid – Seventh Indication Expands IL‑4/IL‑13 Franchise
Sanofi S.A. (NASDAQ: SNY) announced that Dupixent (dupilumab) has received marketing approval from Japan’s Ministry...
Bio‑Thera Expands Intas Partnership to India – BAT2506 Golimumab Biosimilar Now Licensed Across US, Canada, and India
Bio‑Thera Solutions Inc. (SHA: 688177) has expanded its strategic partnership with Intas Pharmaceuticals Ltd., granting...