NEXSPIKE is Moderna’s third product to receive a positive CHMP opinion alongside Spikevax (COVID-19 Vaccine, mRNA) and ...

The decision applies to adolescents and adults and aligns with earlier US authorization for higher-risk groups.

The U.S. Food and Drug Administration is considering adding the strongest safety warning available to COVID-19 vaccines, ...

Moderna on Monday said that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the marketing authorization of mNexspike, a new Covid-19 vaccine. The committee's ...

A black box warning is the most serious from the U.S. Food and Drug Administration, and critics say there is no justification ...

The U.S. is in "big danger" of falling behind in vaccine technology research as government funding declines and vaccine ...

Vaccine makers are down after the FDA says it will enforce stricter vaccine approval rules after alleged child deaths ...

Vinay Prasad, a top FDA official, blamed COVID shots for playing a role in the deaths of 10 children in a memo he sent to ...

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans.

The Morrison government went against departmental advice to continue negotiating with another tenderer for mRNA vaccines and ...

The FDA is reportedly considering the addition of high-level warning labels to COVID vaccines, a move that some experts say ...

The Food and Drug Administration is investigating whether COVID-19 vaccines caused deaths in adults, as part of a safety ...