News about Clinical Trials

Johnson & Johnson Submits sBLA to US FDA for IMAAVY in Warm Autoimmune Hemolytic Anemia

Johnson & Johnson has filed a supplemental biologics application seeking US approval of IMAAVY (nipocalimab) for warm autoimmune hemolytic anemia, a rare disorder with no currently approved treatments.

Clinical Trials | 26/02/2026 | By News Bureau

Hansa Biopharma's Imlifidase BLA Accepted by US FDA for Priority Review

FDA accepts Hansa Biopharma’s BLA for imlifidase, supported by strong Phase III ConfIdeS data demonstrating significant kidney function improvement in highly sensitized transplant patients.

Clinical Trials | 20/02/2026 | By News Bureau |  147

Novartis' Remibrutinib Shows Positive Phase III Results in Chronic Inducible Urticaria

Pivotal RemIND trial meets primary endpoint across three major CIndU subtypes, positioning oral remibrutinib as a potential first targeted therapy for inducible chronic hives.

Clinical Trials | 19/02/2026 | By News Bureau

FDA Accepts Bristol Myers Squibb's NDA for Iberdomide Combination in Relapsed/Refractory Multiple Myeloma

Iberdomide, an investigational oral CELMoD therapy, is under FDA review in combination with daratumumab and dexamethasone for patients with relapsed or refractory multiple myeloma.

Clinical Trials | 19/02/2026 | By News Bureau

Duvakitug Shows Durable Efficacy in Ulcerative Colitis and Crohn's Disease in Long-Term Study

Long-term extension data show sustained remission and endoscopic response with duvakitug in ulcerative colitis and Crohn’s disease, strengthening its position as a potential next-generation TL1A therapy.

Clinical Trials | 18/02/2026 | By News Bureau

Genentech's Gazyva Shows Strong Phase III Results in Primary Membranous Nephropathy

Phase III MAJESTY trial shows Gazyva significantly improves complete remission rates in primary membranous nephropathy, potentially paving the way for the first targeted therapy for the condition.

Clinical Trials | 17/02/2026 | By News Bureau

Lilly's Retevmo Shows Significant Benefit in Early-Stage RET+ Lung Cancer in Phase III Trial

LIBRETTO-432 study demonstrates statistically significant improvement in event-free survival as adjuvant therapy for stage II–IIIA RET fusion-positive NSCLC.

Clinical Trials | 17/02/2026 | By News Bureau

CStone's CS2009 Secures U.S. FDA IND Clearance for Phase II Trial in Advanced Solid Tumours

CStone Pharmaceuticals has received U.S. FDA IND clearance to begin a Phase II trial of its trispecific antibody CS2009 for advanced solid tumours, advancing its global immunotherapy development programme.

Clinical Trials | 16/02/2026 | By News Bureau

Innovent Doses First Patient in Phase III Trial of IBI354 for First-Line HER2-Positive Advanced Breast Cancer

HeriCare-Breast01 study evaluates next-generation HER2 ADC against standard THInnovent BiologicsP regimen, following promising phase I/II efficacy and safety data presented at ASCO 2025.

Clinical Trials | 16/02/2026 | By News Bureau

SOFIE Biosciences doses first patient in Phase III FAPI-PRO trial for pancreatic cancer imaging

SOFIE Biosciences has dosed the first patient in its Phase III FAPI-PRO trial evaluating 18F-FAPI-74 PET/CT for detecting metastatic pancreatic ductal adenocarcinoma, with 18 sites planned across 24 months.

Clinical Trials | 13/02/2026 | By News Bureau