News about Regulation

Japan Approves Wegovy for MASH

Wegovy subcutaneous injection has been approved in Japan for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), becoming the first approved therapy for the disease in the country.

Regulation | 22/06/2026 | By News Bureau

Sanofi Secures Japan Approval for Subcutaneous Formulation of Sarclisa

Sanofi’s Sarclisa subcutaneous formulation has been approved in Japan for patients with multiple myeloma. The approval is supported by the Phase 3 IRAKLIA study and marks the second global approval after the EU.

Regulation | 22/06/2026 | By News Bureau

Chugai Pharma's Avastin Secures Approval in Japan for Additional Indication

Chugai Pharma’s Avastin has received approval in Japan for an additional indication, becoming the world’s first therapeutic option for neurofibromatosis type 2. The approval is supported by positive phase 2 clinical study results.

Regulation | 22/06/2026 | By News Bureau

Japan Approves Rituxan for Steroid-Dependent Nephrotic Syndrome in Adults

Rituxan (rituximab) IV 100 mg and 500 mg receives regulatory approval for adult-onset frequently relapsing or steroid-dependent nephrotic syndrome, with phase 3 data showing an 87.4 percent relapse-free rate at week 49.

Regulation | 20/06/2026 | By News Bureau |  116

Health Ministry Bans 16 Fixed Dose Combination Drugs in India

The Union Health Ministry has banned the manufacture, sale, and distribution of 16 Fixed Dose Combination (FDC) drugs in India, citing public health concerns and the need to ensure only safe, effective, and scientifically justified medicines remain available in the market.

Regulation | 20/06/2026 | By News Bureau

US FDA Approves Additional Indication for CAPVAXIVE

The US Food and Drug Administration (FDA) has approved an expanded indication for CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) for children and adolescents aged 2-17 years at increased risk of pneumococcal disease, broadening protection against serious pneumococcal infections in vulnerable pediatric populations.

Regulation | 20/06/2026 | By News Bureau |  137

Regulators Warn against Promotion of Newly Licensed Weight-Loss Medicines

MHRA, ASA, and GPhC have warned businesses against promoting newly licensed prescription-only and unlicensed weight-loss medicines, reinforcing compliance with advertising regulations and public health protections.

Regulation | 20/06/2026 | By News Bureau

Alembic Pharmaceuticals Announces US FDA Tentative Approval for Binimetinib Tablets, 45 mg

Alembic Pharmaceuticals has received the US Food and Drug Administration (FDA) tentative approval for Binimetinib Tablets 45 mg, a generic version of Mektovi (binimetinib).

Regulation | 20/06/2026 | By News Bureau |  136

US FDA Approves Utebzi for Adult Patients with Complicated UTIs

The US Food and Drug Administration (FDA) has approved GSK’s Utebzi (tebipenem pivoxil) for adults with complicated Urinary Tract Infections (cUTIs), becoming the first and only oral carbapenem antibiotic available. The approval is based on the phase 3 PIVOT-PO trial, which demonstrated non-inferiority to standard intravenous antibiotic treatment.

Regulation | 19/06/2026 | By News Bureau |  111

US FDA Accepts Roche's Lunsumio-Polivy Filing for Relapsed Large B-Cell Lymphoma

The US Food and Drug Administration (FDA) has accepted Roche’s supplemental Biologics License Application for the Lunsumio and Polivy combination in relapsed or refractory large B-cell lymphoma. The filing is supported by Phase 3 SUNMO study data showing a 59 percent reduction in the risk of disease progression or death.

Regulation | 19/06/2026 | By News Bureau |  107