Tag: FDA

News

Novartis Ianalumab Clinches FDA Breakthrough Status, Aiming to Be First Targeted Treatment for Sjögren’s Disease

novartis

Novartis reaches a historic milestone in immunology as the FDA grants Breakthrough Therapy designation to ianalumab for Sjögren’s disease. Backed by successful Phase III NEPTUNUS trials, this dual-action monoclonal antibody is poised to become the first targeted therapy for this chronic autoimmune condition. With global regulatory submissions planned for early 2026, ianalumab represents a significant leap forward for millions of patients currently facing an immense unmet medical need.

News Regulatory Approval

FDA Approves First-Ever Weight-Loss Pill: Novo Nordisk’s Wegovy Pill to Launch in January

novo nordisk

The FDA has officially approved the first-ever oral version of Wegovy, a once-daily tablet from Novo Nordisk. With clinical trials showing a 16.6% average weight loss, this landmark approval offers a needle-free alternative for obesity management and cardiovascular protection starting in January 2026.

Regulatory Healthcare & Pharmaceuticals News Weight-loss Drugs

Novo Nordisk Seeks FDA Approval for Powerful New Combination Obesity Drug, CagriSema, Following Strong Phase 3 Data

novo nordisk

Novo Nordisk has officially submitted a New Drug Application to the FDA for CagriSema, a first-of-its-class once-weekly injection for chronic weight management. Combining semaglutide with a novel amylin analogue, clinical data from the REDEFINE program shows the treatment can achieve over 20% weight loss in adults with obesity.

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 Autoimmune Diseases Healthcare & Pharmaceuticals News

Sanofi Anticipates Delay in FDA Regulatory Decision for Tolebrutinib in Non-Relapsing Secondary Progressive Multiple Sclerosis

sanofi

Sanofi anticipates that the US regulatory decision for its investigational drug, tolebrutinib, for non-relapsing secondary progressive multiple sclerosis (nrSPMS) will be delayed beyond the previous December 2025 target action date, with further guidance expected by the end of Q1 2026.

Regulatory Approval Healthcare & Pharmaceuticals News Oncology

U.S. FDA Approves AKEEGA®, the First Precision Therapy for BRCA2-Mutated Metastatic Prostate Cancer, Slashing Disease Progression Risk by 54%

JohnsonAndJohnson

A major advance in prostate cancer treatment: The FDA has approved AKEEGA® for BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). This first-of-its-kind precision therapy, combining niraparib and abiraterone, demonstrated a significant 54% reduction in the risk of disease progression or death compared to the standard of care. This milestone offers a personalized, highly effective option for patients with this aggressive genetic mutation.

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.