News | June 26, 2025
Philogen withdraws marketing authorization application for Nidlegy in EU
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
These results represent critical milestones for Philogen, as Fibromun has the potential to become second product to successfully complete multinational clinical trials with registration potential
Sun Pharma will have the exclusive worldwide rights to commercialise Fibromun
Sun Pharma will have exclusive rights to commercialise Nidlegy for indications of skin cancers in the territories of Europe, Australia and New Zealand. Philogen will complete pivotal clinical trials for the product in Europe
PIVOTAL is an open label, randomized, multicenter, Phase III trial evaluating Nidlegy as a neoadjuvant intralesional therapy
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