The U.S. Food and Drug Administration authorized emergency use of the first over-the-counter Covid-19 antigen test, which can be used at home.

A panel of outside advisers to the U.S. Food and Drug Administration is meeting on Dec. 10 to weigh whether to recommend that the regulatory agency authorize Pfizer’s coronavirus vaccine for emergency use, one of the last steps before vaccinations could begin.

The mayor of San Francisco ordered new lockdowns and business restrictions across the Bay Area in the face of the Covid-19 surge, as political leaders nationwide ramp up pressure on Americans to stay home until vaccines can be distributed.

U.S. leaders urgently called on Americans to wear masks and threatened even more drastic stay-at-home orders after deaths from the coronavirus set a single-day record, with two people dying every minute.

The U.S. Food and Drug Administration will make public reviews of all data and information regarding the emergency use authorization (EUA) granted to Covid-19 drugs and vaccines.

2019 was a good year for the pharma industry, even as questions on value kept coming; but 2020 brought a pandemic that raised an “all hands on deck” attitude as well as business challenges.

White House Reverses Course, Approves New FDA COVID-19 Vaccine Guidelines Published: Oct. 7, 2020 By Alex Keown BioSpace   The White House has reversed its position on new vaccine guidelines proposed […]

Former U.S. Food and Drug Administration Commissioner Scott Gottlieb criticized current FDA Commissioner Stephen Hahn’s comments to the Financial Times that he would potentially fast-track a Covid-19 vaccine before clinical trials are done if it was “appropriate.”

The head of the U.S. Food and Drug Administration is willing to fast-track a Covid-19 vaccine as quickly as possible, the Financial Times reported him as saying in a published interview.

The U.S. Food and Drug Administration authorized the use of blood plasma from patients who have recovered from Covid-19 as a treatment for the disease.