FDA Delays Decision on Moderna RSV Shot by 3 Weeks
The agency was originally scheduled to announce its call on Sunday. The company said it hadn’t flagged any issues with the ...
FierceBiotech14 día(s)
FDA delays decision on Moderna's RSV shot until the end of May
The FDA needs a few more weeks to decide the fate of Moderna's RSV vaccine, the company announced. A decision is now slated ...
BioPharma Dive14 día(s)
FDA delays decision on Moderna RSV vaccine
Moderna on Friday said the Food and Drug Administration has postponed an approval decision on its experimental vaccine for respiratory syncytial virus due to “administrative constraints,” extending a ...
US FDA pushes decision on Moderna's RSV vaccine to end of this month
The U.S. drug regulator has pushed back its decision on Moderna's respiratory syncytial virus (RSV) vaccine due to ...
Moderna Says FDA Delaying Decision on RSV Vaccine Approval
US regulators’ decision on whether to approve Moderna Inc.’s vaccine for RSV has been delayed due to “administrative constraints” at the Food and Drug Administration, the company said.
Moderna Stock Slips as FDA Delays RSV Vaccine Approval
Key Takeaways Moderna said the Food and Drug Administration (FDA) has delayed its approval decision for the respiratory ...
Monthly Prescribing Reference14 día(s)
FDA Decision on Moderna’s mRNA-Based RSV Vaccine Delayed
The FDA is working to conclude its review by the end of May 2024. The Food and Drug Administration (FDA) has informed Moderna that its review of the Biologics License Application (BLA) for mRNA-1345, ...
The Business Journals14 día(s)
FDA delays decision date for Moderna's RSV vaccine
Just days before its initial deadline, U.S. regulators say they need more time to decide whether or not to approve Moderna's respiratory syncytial virus (RSV) vaccine. Just days before its ...
Stars and Stripes14 día(s)
Moderna says FDA delaying decision on RSV vaccine approval
US regulators’ decision on whether to approve Moderna Inc.’s vaccine for RSV has been delayed due to “administrative constraints” at the Food and Drug Administration, as the company works ...