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US regulators have authorised the first coronavirus vaccine for emergency use, marking an inflection point in the pandemic and kicking off what's set to be the largest vaccination campaign in US history.

On a hot afternoon in August, Debbie Honeycutt walked into the crowded waiting room of the Medical Center for Clinical Research, an experimental-treatment facility tucked inside a squat office building in San Diego. She was volunteer number four hundred…

NEW YORK, Dec. 9, 2020 /PRNewswire/ -- The Michael J. Fox Foundation for Parkinson's Research (MJFF) has received the Advocacy/Policy Award from the Reagan-Udall Foundation for the Food and Drug Administration. MJFF is the second…

Tom Skelton, CEO of Surescripts, recently spoke with Dr. Amy Abernethy of the FDA, about the impact of COVID-19 and the evolving data needs of public health.    

ZURICH/LONDON (Reuters) - With COVID-19 vaccine trial results looking positive, governments and pharmaceutical firms face their next daunting challenge: convincing the world to get inoculated. Public resistance to vaccines has been much discussed this…

Reagan-Udall receives $250,000 from Rockefeller Foundation for COVID-19 Diagnostics Evidence Accelerator

President Donald Trump has often touted the role of the military in distributing a COVID-19 vaccine, but health officials close to the process who are concerned about public distrust are taking pains to say the federal government won’t actually be…

Black Americans distrust the government so much they're not participating in large numbers in COVID-19 clinical trials, and many say they won't get a COVID-19 vaccine – at least not until many others get it. Although the first two large clinical…

Extraordinary and unusual measures may be needed to rapidly develop and distribute a vaccine against SARS-CoV-2, but those efforts should not compromise the safety and efficacy of any product that reaches the market, according to the FDA Vaccines and…

Concerns raised yesterday by an advisory group to the U.S. Food and Drug Administration (FDA) may once again tap the brakes on Operation Warp Speed, the U.S. government’s $10.8 billion push to rapidly move candidate COVID-19 vaccines from concept to…