#Food and Drug Administration

David Kessler will helm Operation Warp Speed as AIDS activists urge the United States to supply the world with COVID-19 vaccines.

Pfizer/BioNTech’s coronavirus vaccine is 95% effective for preventing symptomatic illness.

In the United States, an FDA expert advisory panel voted on December 10 to recommend emergency use authorization.

The test can detect COVID-19 and influenza A and B in samples collected at home and shipped to a lab.

With the first vaccines expected within weeks, a CDC advisory panel votes on how to prioritize access.

Moderna has requested emergency use authorization for its mRNA vaccine candidate.

Agency grants emergency authorization for antibody cocktail given to President Trump.

Upcoming hearing on the Pfizer/BioNTech vaccine will be livestreamed on YouTube, Facebook and Twitter.

Arthritis drug Olumiant (baricitinib) can be used in combination with remdesivir.

The new test kit, available by prescription, uses a self-collected nasal swab sample.

The panel’s goal is to ensure that all coronavirus therapeutics approved by the government are safe and effective for African Americans.

Plasma from recovered patients recently received a controversial FDA emergency use authorization as a potential treatment for COVID-19.

“The SalivaDirect test...is yet another testing innovation game changer that will reduce the demand for scarce testing resources.”

The FDA offers researchers new guidance to help keep trials on track.