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Biotech Stocks Facing FDA Decision In January 2021

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As 2020 draws to a close, it's time to take a look back at some of the regulatory news that made headlines in December and look ahead at what's in store for January 2021.

Two COVID-19 vaccines secured Emergency Use Authorization in the U.S. - Pfizer/BioNTech's BNT162b2 on Dec.11, and Moderna's mRNA-1273 on Dec.18.

The month of December also witnessed a number of firsts on the regulatory front.

Gallium 68 PSMA-11 was green-lighted by the FDA on December 1, becoming the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

Quest Diagnostics' RC COVID-19 +Flu RT-PCR Test, which was authorized by the U.S. regulatory agency on December 4, is the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B.

On December 15, the FDA issued an emergency use authorization for Ellume COVID-19 Home Test, which marks the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19.

Myovant Sciences' (MYOV) Orgovyx secured FDA nod on December 18, becoming the first oral hormone therapy for treating advanced prostate cancer.

Now, let's take a look at the biotech companies whose drugs are at the FDA altar awaiting a decision in January 2021.

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