The FDA’s top vaccine regulator outlines proposed changes to the vaccine evaluation process in an internal memo.

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 ...

Shares of several major vaccine makers lost ground Monday following a report U.S. vaccine approval rules could become ...

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

Moderna recently faced pressure after the U.S. Food and Drug Administration announced plans to require more rigorous safety ...

Revenue -- $1.9 billion reported for the quarter, compared to prior sales cycles impacted by earlier U.S. COVID-19 vaccine ...

CAMBRIDGE, MA / ACCESS Newswire / September 16, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced positive preliminary immunogenicity data for the 2025-2026 formula of Spikevax®, which targets the LP ...

Moderna announced this weekend that the Food and Drug Administration approved its lower-dose Covid-19 vaccine for adults 65 and older, as well as people ages 12 to 64 with at least one medical ...

FRANKFURT (Reuters) - Moderna and Pfizer-BioNTech are in a tight race to launch their COVID-19 vaccines in Europe after both applied for emergency EU approval on Tuesday, though there was uncertainty ...

Moderna Inc. fell in premarket trading Monday after the Food and Drug Administration said in a memo late last week it would place new restrictions on which vaccines hit the market.

Pfizer, BioNTech request EU conditional approval Regulator says panel to meet Dec 29 at latest Rival Moderna also submits EU filing for its shot Both groups have applied for U.S. emergency use ...