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
December 26, 2025 08:42 ET Third quarter economic growth data from some major economies including the U.S. were the main news in this holiday shortened week. GDP growth and industrial production data from the U.S. helped to boost morale, while the consumer confidence survey results were less upbeat. In Europe, the quarterly economic growth data from the U.K. drew attention, while the minutes of the Australian central bank’s latest policy session was in focus in Asia.