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.

Moderna has scrapped plans to build an mRNA plant in Japan. Otsuka and Lundbeck's proposal for Rexulti as part of a PTSD ...

BioMarin Pharmaceuticals is one of many biotech companies that’s laid off workers over the past two years. Its office in ...

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 ...

(Reuters) -U.S. Health Secretary Robert F. Kennedy Jr., a long-time vaccine skeptic, has been making sweeping changes to reshape vaccine, food and medicine policies. The most far-reaching of his moves ...

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 ...

Sanofi has moved to bolster its vaccines business by reaching a deal to buy London, UK-based biotech Vicebio, which was ...