Moderna on Tuesday asked the Food and Drug Administration for full U.S. approval of its Covid-19 vaccine — the second drugmaker in the U.S. to seek a biologics license that will allow it to market the ...
The company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.
The updated mRNA vaccines target the LP.8.1 variant of SARS-CoV-2. The Food and Drug Administration (FDA) has approved the 2025-2026 formulations of Moderna’s COVID-19 vaccines Spikevax ® and ...
WASHINGTON -- Moderna is applying for full government approval for its COVID-19 vaccine. The company said it is submitting trial data to the Food and Drug Administration on a rolling basis over the ...
Moderna Inc. fell in premarket trading Monday after the Food and Drug Administration said in a memo late last week it would place new restrictions on which vaccines hit the market. Vinay Prasad, a top ...