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FDA Authorizes BinaxNOW COVID-19 Ag Card Home Test americanpharmaceuticalreview
December 18, 2020
The U.S. Food and Drug Administration (FDA) issued a new emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test which is authorized for use by patients at home with a prescription.
US FDA Advisory Committee supports EUA for Moderna’s COVID-19 vaccine expresspharma
December 18, 2020
Moderna confirmed that the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an emergency use authorisation (EUA) for the company’s COVID-19 vaccine candidate ...
binx health receives EUA Authorizing at-Home COVID-19 Sample Collection by Universities, Employers americanpharmaceuticalreview
December 16, 2020
binx health has received an amendment to its COVID-19 Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), this time for centralized specimen collection kit distribution and retrieval by large partners.
Pfizer seeks EUA for COVID-19 vaccine in India expresspharma
December 07, 2020
Pfizer has written to the Drugs Controller General of India, applying for emergency use authorisation (EUA) of its coronavirus vaccine in India, the first to do so, CNN-News18 reported citing a government source.
Moderna applies for regulatory authorisation for COVID-19 vaccine europeanpharmaceuticalreview
December 03, 2020
The company has submitted for Emergency Use Authorization in the US and Conditional Marketing Authorization in Europe for its mRNA-1273 vaccine against COVID-19.
Pfizer, BioNTech Submit EUA Request for COVID-19 Vaccine americanpharmaceuticalreview
November 24, 2020
Pfizer and BioNTech announced they will submit a request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine ..
Regeneron's COVID-19 Antibody Cocktail Gets EUA contractpharma
November 24, 2020
Expects to have treatment doses ready for approximately 80,000 patients by the end of November, and 200,000 by the first week of January.
Helix Receives Expanded EUA for Helix® COVID-19 Test americanpharmaceuticalreview
October 30, 2020
Helix has received an expanded Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Helix COVID-19 Test. With this expansion, individuals can now self-collect their samples without the supervision of a healthcare ...
Lilly, U.S. Govt. Enter Supply Pact for Bamlanivimab COVID-19 Treatment contractpharma
October 29, 2020
Initial agreement is for 300,000 vials of the investigational neutralizing antibody with potential for purchase of an additional 650,000 vials.
Centogene Receives EUA for SARS-CoV-2 RT-PCR Assay americanpharmaceuticalreview
October 23, 2020
Centogene announced the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for CentoSure, the company's latest SARS-CoV-2 RT-PCR test.

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