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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Business News
May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.