This week, vaccine manufacturer Moderna revealed that Vinaya Prasad, the top vaccine regulator at the Food and Drug Administration (FDA)—which is a part of HHS— declined to even consider the safety ...

By Ahmed Aboulenein WASHINGTON, Feb 23 (Reuters) - U.S. Food and Drug Administration Commissioner Marty Makary on Monday defended his agency's position and record on mRNA vaccines, days after it ...

A challenging public health policy landscape under health secretary Robert F. Kennedy has vaccine makers rethinking developing for the U.S. market.

The FDA is slated to make a decision on the flu shot on Aug. 5, which will allow Moderna to make the vaccine available for the upcoming influenza season.

The company revised its plan to seek full approval for middle-aged adults and accelerated approval for seniors.

The U.S. Food and Drug Administration announced recently that it will not review Moderna’s mRNA flu vaccine, despite late-stage trials showing it was safe and effective. The rejection has many in and ...

The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA ...

The Food and Drug Administration (FDA) has backtracked its initial decision last week of refusing to review Moderna’s mRNA ...

MAINZ, Germany, and OSLO, Norway, September 18, 2023 — BioNTech SE (Nasdaq: BNTX, “BioNTech”, "the Company") and the Coalition for Epidemic Preparedness Innovations (CEPI) today announced a strategic ...

Center for Biologics Evaluation and Research (CBER) issued Moderna a refusal-to-file letter for its mRNA influenza vaccine, mRNA-1010. Two weeks later, under mounting pressure from the scientific ...