The European Union's drug regulator has recommended approval of Moderna's updated formulation of COVID-19 shot Spikevax, the ...

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

An expert panel of the EU drug regulator, the European Medicines Agency (EMA) on Friday recommended marketing authorizations ...

Mary Talley Bowden, MD, founder of Americans for Health Freedom, an advocacy group that has lobbied against mRNA shots, ...

Moderna stock rises on flu vaccine data and FDA approvals, while healthcare stocks remain under pressure amid political ...

In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...

Respiratory syncytial virus (RSV) poses a significant, often overlooked, risk for serious cardiovascular complications in ...

The CDC recently updated RSV vaccine recommendations to include certain adults aged 50 and up. When is the best time to get ...

Earlier this summer the FDA asked Moderna for more efficacy data on its flu vaccine before it could review an mRNA-based ...

Moderna, already in cash-saving mode amid uncertain vaccine dynamics, is backing off from its plans to construct an mRNA drug ...

State Surgeon General Dr. Joseph Ladapo is speaking to the community about the updated federal recommendations for healthy ...

Moderna's Spikevax vaccine has been fully approved for children with high-risk conditions, the first vaccine to do so.