Bioniz Therapeutics has secured orphan drug designation for BNZ-1 from the European Commission (EC) for the treatment of cutaneous T-cell lymphoma (CTCL), a rare type of skin cancer. Previously, BNZ-1 was given orphan drug designation by the US Food and Drug Administration (FDA). Recently, Bioniz Therapeutics wrapped up a phase 2 study of BNZ-1 in […]
Libtayo EMA approval : The European Commission has given conditional approval for Libtayo (cemiplimab) for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), which is one of the most commonly diagnosed skin cancers. Libtayo, which is a fully-human monoclonal antibody targeting the immune checkpoint receptor programmed cell death […]
In a significant development for melanoma treatment, the European Commission (EC) has granted Novartis approval for its combination therapy of Tafinlar (dabrafenib) and Mekinist (trametinib). This approval is specifically for adjuvant therapy in stage III melanoma patients who are positive for the BRAF V600 mutation and have undergone complete surgical resection. The approval is based […]