Biotech Stocks Facing FDA Decision In November 2020

fda oct23

It's more than 7.5 months since the World Health Organization declared COVID-19 a pandemic. The number of confirmed coronavirus cases worldwide has surpassed 42.5 million as of this writing. The U.S. tops the list with 8.57 million cases and over 224,000 deaths.

A total of 283 tests for COVID-19 have been authorized by FDA under the Emergency Use Authorization and these include 221 molecular tests, 56 antibody tests, and 6 antigen tests.

On October 22, the FDA approved Gilead's (GILD) Veklury (remdesivir), the first drug for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization.

Another notable first to be achieved on the regulatory front is the approval of Regeneron Pharmaceuticals' (REGN) Inmazeb, the first FDA-approved treatment for Ebola virus infection in adult and pediatric patients, on October 14.

The month also saw the first drug regimen approved for mesothelioma in 16 years when the drug combination of Opdivo and Yervoy was greenlighted by the FDA on October 2 for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery.

Let's take a look at the companies that await a ruling from the FDA in November.

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