In January 2026, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending an extension of the indication for Noxafil (posaconazole) gastro-resistant tablets to include treatment of invasive aspergillosis in adults and pediatric patients from 2 years of age weighing more than 40 kg. This development reflects the evolving therapeutic landscape for antifungal treatments.
In March 2026, the FDA issued Import Alert 16-124, focusing on aquaculture seafood products due to unapproved drugs. While not directly related to amphotericin B, this alert underscores the FDA's vigilance in monitoring imports for compliance with U.S. regulations.
In February 2026, the WHO published the 24th edition of the Model List of Essential Medicines, reaffirming the inclusion of amphotericin B as a critical antifungal agent. This inclusion highlights the ongoing global recognition of amphotericin B's importance in treating severe fungal infections.
In July 2025, the NPPA revised the ceiling price for liposomal amphotericin B injection 50 mg to ₹3,000 per vial, aiming to enhance affordability and accessibility of this essential medication in India.
In June 2025, the WHO Prequalification Programme prequalified an amphotericin B product manufactured by Gilead Sciences Ireland UC, facilitating its procurement by UN agencies and ensuring access to quality-assured medicines.
These developments reflect the dynamic regulatory and market environment surrounding amphotericin B, emphasizing the need for continuous monitoring and compliance to maintain market access and meet global health needs.
