U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024
Announces changes to commercial organization to prepare for multiple product launches in 2024 and 2025
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial and unmet need for additional therapeutic options for certain types of melanoma
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
The open-label, multicenter, randomized Phase 1 trial is designed to evaluate the safety and immunogenicity of experimental HIV trimer mRNA vaccines
The immunogens being tested in IAVI G002 were developed by scientific teams at IAVI and Scripps Research and will be delivered via Moderna's mRNA technology
Carisma to receive US $ 45 million up-front cash payment and investment by Moderna in the form of a US $ 35 million convertible note
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