Moderna announced on Wednesday it has completed its submission to the US Food and Drug Administration for full approval of its COVID-19 vaccine for people age 18 and older, and Pfizer and BioNTech ...
Americans could soon see a major increase in access to COVID-19 vaccine booster shots. On Friday, the U.S. Food and Drug Administration (FDA) announced its Vaccines and Related Biological Products ...
The company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.
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 ...
The Food and Drug Administration (FDA) expanded the approval of Moderna’s RSV vaccine late Thursday to include people 18 to ...
Pfizer Inc.'s (NYSE:PFE) COVID-19 vaccine for children under five may lose U.S. Food and Drug Administration authorization this fall, raising the possibility of supply shortages and prompting Moderna ...
Expects 2025 revenue of approximately $1.9 billion (unaudited), $100 million above midpoint communicated on 3Q25 ...
Moderna CEO Stéphane Bancel positions 2026 as a catalyst-rich year driven by new vaccine launches, late-stage oncology data, ...
In this week’s edition of InnovationRx, we look at Sarepta’s showdown with the FDA, Moderna’s use of quantum computers, a new top drug regulator at the FDA, ARCH Venture’s latest biotech company, and ...