Tag: FDA Approval

Regulatory Approval Autoimmune Diseases News

ICOTYDE FDA Approval: J&J’s First-Line Oral Peptide Breakthrough for Plaque Psoriasis Treatment

JohnsonAndJohnson

ohnson & Johnson has announced FDA approval of ICOTYDE (icotrokinra), the first and only IL-23R targeted oral peptide designed for first-line systemic treatment of moderate-to-severe plaque psoriasis. This groundbreaking approval represents a paradigm shift in dermatology, offering patients unprecedented efficacy with complete skin clearance in over 70% of clinical trial participants.

Regulatory Approval News Oncology

U.S. FDA Approves Venclexta and Acalabrutinib Combination for First-Line CLL Treatment

AbbVie

On February 20, 2026, the U.S. FDA approved the combination of Venclexta (venetoclax) and acalabrutinib for the first-line treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This landmark decision establishes the first and only all-oral, fixed-duration (time-limited) regimen for previously untreated patients, offering a significant alternative to continuous therapy or chemoimmunotherapy

Regulatory Approval Healthcare & Pharmaceuticals News

Johnson & Johnson Secures FDA Approval for TRUFILL n-BCA to Treat Chronic Subdural Hematoma

JohnsonAndJohnson

Johnson & Johnson MedTech has secured FDA approval for an expanded indication of the TRUFILL n-BCA Liquid Embolic System. This new approval allows for the treatment of chronic subdural hematoma (cSDH) via middle meningeal artery (MMA) embolization, offering a minimally invasive solution to significantly reduce the high recurrence rates associated with traditional surgery.

Regulatory Approval Healthcare & Pharmaceuticals News

FDA Approves GSK’s Exdensur (depemokimab), the First Twice-Yearly Biologic for Severe Asthma

GSK - GlaxoSmithKline

The U.S. FDA has approved GSK’s Exdensur (depemokimab), a revolutionary ultra-long-acting biologic for severe eosinophilic asthma. As the first treatment of its kind to require only two doses per year, Exdensur promises to improve patient adherence and significantly reduce the frequency of life-threatening asthma attacks.

Regulatory Approval Autoimmune Diseases News

U.S. FDA Approves Amgen’s UPLIZNA® for Generalized Myasthenia Gravis in Adults

amgen

The FDA has approved Amgen’s UPLIZNA for adults with generalized myasthenia gravis (gMG) who are anti-AChR or anti-MuSK antibody positive. UPLIZNA is the first and only CD19-targeted B-cell therapy approved for this indication, offering a convenient dosing schedule of just two maintenance doses per year following the initial loading regimen. The approval is based on strong efficacy data from the Phase 3 MINT trial.

Regulatory Approval Healthcare & Pharmaceuticals News

Novartis Receives FDA Approval for Itvisma, Expanding Gene Therapy to Older Children and Adults with SMA

novartis

Novartis has secured FDA approval for Itvisma (onasemnogene abeparvovec-brve), marking a historic milestone as the first gene replacement therapy for spinal muscular atrophy (SMA) available to children aged two and older, teens, and adults. This one-time intrathecal injection offers a “game-changing” new treatment option for patients previously ineligible for gene therapy.

Regulatory Approval Healthcare & Pharmaceuticals News Oncology

U.S. FDA Approves PADCEV® and KEYTRUDA® Combo for Patients with Bladder Cancer

pfizer news

The FDA has granted approval for PADCEV® plus KEYTRUDA® as a perioperative treatment for cisplatin-ineligible patients with muscle-invasive bladder cancer (MIBC). Clinical data reveals the combination reduces the risk of recurrence, progression, or death by 60% compared to surgery alone, marking a major shift in the standard of care.

Regulatory Approval Healthcare & Pharmaceuticals Rare Diseases

U.S. FDA Approves KYGEVVI, the First and Only Treatment for Ultra-Rare Mitochondrial Disease TK2d

UCB News

The U.S. FDA granted approval to KYGEVVI for treating adults and children with Thymidine Kinase 2 Deficiency (TK2d), an ultra-rare, life-threatening mitochondrial disease. Developed by UCB, KYGEVVI is the first and only approved therapy for TK2d, demonstrating a profound 86% reduction in the risk of death and significant improvement in motor function for patients with early-onset disease.