01/10/2026 Cullinan Initiates NDA Submission for Zipalertinib + Chemotherapy in 1L EGFR Exon 20ins NSCLC Trethera receives FDA Fast Track Designation for TRE-515 combination strategy in KRAS G12C-Mutant NSCLC Replimune announces US launch of TUDRIQEV™ for advanced Melanoma Cullinan Initiates NDA Submission for Zipalertinib + Chemotherapy in 1L EGFR Exon 20ins NSCLC (Ref) Cullinan Therapeutics announced the initiation of a US FDA New Drug Application (NDA) submission under the

06/08/2026 US FDA Grants Accelerated Approval for Replimune’s TUDRIQEV + Nivolumab in Advanced Melanoma US FDA Grants Accelerated Approval for Replimune’s TUDRIQEV + Nivolumab in Advanced Melanoma (Ref) Replimune announced that the US FDA has granted accelerated approval for TUDRIQEV™ (vusolimogene oderparepvec-wtpg, formerly RP1; type 1 (HSV-1) oncolytic viral therapy) in combination with nivolumab for patients with unresectable advanced cutaneous Melanoma who have progresse