The FDA’s decision is important for Moderna, which is counting on the shot, known as mRNA-1345, to become ts second marketed product. The vaccine is being developed to prevent disease related to ...
Moderna’s first attempt to expand its commercial activities beyond COVID-19 vaccines, its respiratory syncytial virus (RSV) shot, has suffered a delay in the US. The company said the FDA would ...
The Food and Drug Administration (FDA) has informed Moderna that its review of the Biologics License Application (BLA) for mRNA-1345, an investigational respiratory syncytial virus (RSV) vaccine, will ...
Moderna on Friday said the Food and Drug Administration has postponed an approval decision on its experimental vaccine for ... t expect major delays from here onwards and FDA should be able ...
Moderna will have to consider that after receiving word that the FDA will not meet a May 12 decision date for its respiratory syncytial virus (RSV) vaccine candidate. The vaccine maker said Friday ...
US regulators’ decision on whether to approve Moderna Inc.’s vaccine for RSV has been delayed due to ... get its second product to market. The FDA hasn’t informed Moderna of any issues ...
The Food and Drug Administration (FDA) has informed Moderna that its review of the Biologics License Application (BLA) for mRNA-1345, an investigational respiratory syncytial virus (RSV ...
The Cambridge company said the FDA cited “administrative constraints” in its decision to push ... on its review of the RSV vaccine. “Although regulatory delays are disappointing and usually ...