Iovance Biotherapeutics has submitted a marketing authorization application to the European Medicines Agency for lifileucel to treat advanced melanoma, the company announced in a press release.
Regulatory
EMA validates Philogen and Sun Pharma’s MAA for melanoma
The European Medicines Agency (EMA) has validated Philogen and Sun Pharmaceutical’s marketing authorisation application (MAA) for Nidlegy, a treatment for melanoma.
Tunlametinib Wins Approval in China for NRAS+ Advanced Melanoma After PD-1/PD-L1 Therapy
China’s NMPA has approved tunlametinib for the treatment of patients with NRAS-mutated advanced melanoma after prior anti–PD-1/PD-L1 therapy.
China’s National Medical Products Administration (NMPA) has approved tunlametinib (HL-085) for the treatment of patients with advanced melanoma harboring NRAS mutations who were previously treated with anti–PD-1/PD-L1 therapy.
First China, then the world: new MEK blocker wins melanoma nod
Shanghai-based KeChow Pharma has secured approval in its home country for tunlametinib, a MEK blocker which was discovered and developed by the firm in-house.