If approved, Ameluz would become the first and only photodynamic therapy (PDT) photosensitizer for sBCC in the US
The update reflects long-term clinical trial data showing that many patients with mCSCC or laCSCC experienced lasting responses
cSCC is one of the most common cancers in the U.S. and globally
The patient had been battling DFSP for over eight years, enduring multiple recurrences despite three previous surgeries
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
Will add UNLOXCYT (cosibelimab-ipdl), the first and only FDA-approved anti-PD-L1 treatment for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) to Sun Pharma's global onco-derm franchise
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
PIVOTAL is an open label, randomized, multicenter, Phase III trial evaluating Nidlegy as a neoadjuvant intralesional therapy
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
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