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EUL Listing: MPXV IVD

IVD
Announcement
3 November, 2025 - 13:04 (CET)

Cowingene Monkeypox Typing Detection Kit, manufactured by Taizhou Cowingene Biotech Co., Ltd., has been listed under the WHO Emergency Use Listing (EUL).

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Two HPV assays have been prequalified

IVD
Announcement
3 November, 2025 - 12:44 (CET)

These assays - Aptima HPV 16 18/45 Genotype Assay and the Aptima HPV Assay provide advanced nucleic acid amplification technology for detecting high-risk HPV type

Update on Nitrosamine Impurities

M
29 October, 2025 - 12:12 (CET)

In September 2023, PQT/MED issued a call to manufacturers to revisit and update their risk assessments for Finished Pharmaceutical Products (FPP) containing APIs with vulnerable amine groups.