News about "BTK inhibitor"

UK MHRA Approves Rilzabrutinib for Adults with Immune Thrombocytopenia

Rilzabrutinib has been authorised in the UK for the treatment of adults with immune thrombocytopenia who have had an insufficient response to previous therapies, providing a new treatment option for this rare autoimmune bleeding disorder. The UK MHRA will continue to closely monitor the medicine’s safety and effectiveness following approval.

BTK Inhibitor | 01/06/2026 | By News Bureau

FDA Grants Accelerated Approval to BeOne Medicines' Beqalzi for Relapsed Mantle Cell Lymphoma

BeOne Medicines has secured accelerated US FDA approval for Beqalzi (sonrotoclax) to treat relapsed or refractory mantle cell lymphoma, marking an advancement in targeted therapies for patients with limited treatment options.

BTK Inhibitor | 16/05/2026 | By News Bureau

Novartis Secures EC Approval for First Oral Targeted CSU Drug Rhapsido

Novartis introduces Rhapsido in Europe, offering a first-of-its-kind oral targeted therapy for patients with chronic spontaneous urticaria.

BTK Inhibitor | 28/04/2026 | By News Bureau

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.

BTK Inhibitor | 19/02/2026 | By News Bureau |  226

Roche's Fenebrutinib Matches Ocrevus in Slowing Disability Progression in PPMS Phase III Trial

Phase III FENtrepid study shows oral BTK inhibitor fenebrutinib achieved non-inferiority to Ocrevus in primary progressive multiple sclerosis, reducing disability progression risk by 12 percent with consistent subgroup benefit.

BTK Inhibitor | 10/02/2026 | By News Bureau |  179

Roche's Fenebrutinib Becomes First Investigational Therapy in Over a Decade to Slow Disability Progression in PPMS

Roche reported positive late-breaking Phase III ACTRIMS data showing fenebrutinib reduced disability progression in Primary Progressive Multiple Sclerosis (PPMS), demonstrating non-inferiority to OCREVUS and reinforcing its potential as a first-in-class oral BTK inhibitor.

BTK Inhibitor | 09/02/2026 | By News Bureau |  167

EU Approves Sanofi's Wayrilz as First BTK Inhibitor for Immune Thrombocytopenia

Sanofi has received EU approval for Wayrilz, the first Bruton’s Tyrosine Kinase (BTK) inhibitor indicated for immune thrombocytopenia, offering a novel multi-immune modulation approach. The approval is based on positive results from LUNA 3 study, which demonstrated rapid and durable platelet responses.

BTK Inhibitor | 24/12/2025 | By News Bureau |  169

Roche's Fenebrutinib Delivers Strong Phase III results as a Potential First-in-Class BTK Inhibitor for Multiple Sclerosis

In the pivotal FENtrepid trial, Roche’s BTK inhibitor fenebrutinib demonstrated a meaningful reduction in disability progression in Primary Progressive Multiple Sclerosis (PPMS), performing at least on par with OCREVUS—the current standard and only approved treatment for PPMS.

BTK Inhibitor | 15/11/2025 | By Dineshwori |  284

FDA Approves Novartis's Rhapsido as First Oral BTK Inhibitor for Chronic Spontaneous Urticaria

The US Food and Drug Administration (FDA) has approved Novartis’ Rhapsido (remibrutinib) as an oral treatment for adult patients with chronic spontaneous urticaria (CSU) who continue to experience symptoms despite H1 antihistamine therapy.

BTK Inhibitor | 03/10/2025 | By Dineshwori |  412

US FDA Clears Sanofi's Wayrilz, First BTK Inhibitor for ITP

The US FDA approval was based on the pivotal LUNA 3 phase-III study, in which Sanofi’s Wayrilz met the primary and secondary endpoints, showing a positive impact on sustained platelet counts and other ITP symptoms.

BTK Inhibitor | 30/08/2025 | By Dineshwori |  268