The FDA needs a few more weeks to decide the fate of Moderna's RSV vaccine, the company announced. A decision is now slated ...
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 ...
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 ...
opens new tab respiratory syncytial virus (RSV) vaccine due to "administrative ... "We don't expect major delays from here onwards and FDA should be able to approve this by end of May," Jefferies ...
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 ...
Plexi Images / GHI / UCG / Universal Images Group via Getty Images Moderna said the Food and Drug Administration (FDA ... approval decision for the respiratory syncytial virus (RSV) vaccine.
Moderna announced that the FDA had delayed approval of its RSV vaccine to the end of May due to "administrative constraints" at the agency. The FDA was originally expected to make a decision on ...
Moderna (NASDAQ:MRNA) shares are down just over 1% in early Friday trading after the company said the FDA ... RSV vaccine due to "administrative constraints." However, they remain on track for a ...