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
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
Exothera will manufacture Meissa’s MV-012-968 vaccine candidate under CGMP regulations to supply Phase 2 clinical trials
Pfizer is likely to show GSK significant competition
KRIVIDA TRIVUS detects the specific virus causing a respiratory infection.
The new Beyfortus data are consistent with all data accumulated to date and confirm its strong profile
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
Nirsevimab is the first investigational immunization designed to protect all infants across the RSV season with a single dose
The companies are now preparing to initiate a Phase 1 trial to assess the safety and immunogenicity of BLB-201 in healthy volunteers
The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age
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