Drug Approval | June 01, 2024
Moderna receives U.S. FDA approval for RSV Vaccine mRESVIA
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
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
GAAP net loss of $1.2 billion and GAAP diluted EPS of $(3.07)
The demand in Africa for COVID-19 vaccines has declined
Net product sales in the fourth quarter of 2023 include the recognition of $0.6 billion from deferred revenue, related to Gavi, the Vaccine Alliance
Announces changes to commercial organization to prepare for multiple product launches in 2024 and 2025
The initiation of the second clinical trial in the INTerpath program represents rapid expansion in research for additional tumor types for individualized neoantigen therapy, V940 (mRNA-4157)
The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia
Supply readiness follows months of manufacturing to ensure timely and ample supply
First clinical trial reporting results of an mRNA therapeutic for intracellular protein replacement
Subscribe To Our Newsletter & Stay Updated
