In early 2026, Moderna reported encouraging long-term data for its personalized cancer vaccine mRNA-4157 (V940) in high-risk melanoma, while the FDA granted expedited review and an August 5, 2026 ...

Combined with the administration’s erratic regulation and policymaking, it threatens to undo the salutary ecosystem that made ...

Vaccine advisers to the US Food and Drug Administration will meet Thursday to discuss what information the agency should ask for in considering the go-ahead for vaccinating children under 12 -- ...

Incentives to bring vaccines to market are shrinking. Drugmakers are scaling back research investments and cutting jobs.

FDA launches new AI-powered system to track drug and vaccine side effects in real time, replacing outdated databases and saving $120 million annually.

The top vaccine and biologics drug official in the U.S. Food and Drug Administration will step down in April. The agency made ...

WASHINGTON (AP) — The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday ...

The FDA is considering changes that could reshape how vaccines move from labs to American pharmacies — the most significant proposed shift in vaccine oversight since the early 2000s. While the agency ...

The approval represents a win in what’s been a difficult regulatory environment of late for vaccine makers, and could boost ...

PHILADELPHIA -- Pfizer and BioNTech said Tuesday they have submitted Covid-19 vaccine data on children ages 5 to 11 to the US Food and Drug Administration for initial review, but are not yet seeking ...

The Food and Drug Administration’s vaccine chief, Dr. Vinay Prasad, will depart the agency next month, an FDA spokesperson ...