Emergency Use Authorization

The FDA has expanded the Emergency Use Authorization (EUA) label for Quanterix Corporation's (NASDAQ: QTRX) Simoa SARS-CoV-2 N Protein Antigen Test. The expanded label will include testing with a nasal swab and saliva samples and asymptomatic serial testing with nasal swab...

JPMorgan has downgraded Humanigen Inc (NASDAQ: HGEN) to Underweight from Neutral and withdrew its price target after the FDA rejected its Emergency Use request for lenzilumab for hospitalized COVID-19 patients.  Related Content: See Why Humanigen Stock Is Plunging To 52-...

Moderna Inc (NASDAQ: MRNA) has completed the rolling submission process for its marketing application to the FDA, seeking full licensure of its COVID-19 vaccine. The application is for active immunization to prevent COVID-19 in individuals 18 years of age and older. Moderna has...

Enzo Biochem Inc (NYSE: ENZ) has received an expansion of its FDA Emergency Use Authorization (EUA) for its rapid extraction method on its Ampiprobe SARS-CoV-2 Test System to detect SARS-CoV-2, including the variants. The EUA enables laboratories to immediately use Enzo's faster...

The FDA has granted Emergency Use Authorization (EUA) to Roche Holding AG's (OTC: RHHBY) Cobas SARS-CoV-2 Nucleic acid test for use on the Cobas Liat System. This singleplex test is the first real-time RT-PCR test to identify SARS-CoV-2 infection within 20 minutes, both...

The FDA has authorized a new, lower-dose version of Regeneron Pharmaceuticals Inc’s (NASDAQ: REGN) COVID-19 monoclonal antibody cocktail for those with COVID-19 who are at high risk of progressing to hospitalization. The agency updated the Emergency Use Authorization (EUA...

NRx Pharmaceuticals (NASDAQ: NRXP) has applied with FDA requesting Emergency Use Authorization (EUA) for Zyesami (Aviptadil-acetate) for critically ill COVID-19 patients suffering from respiratory failure. Consistent with previously announced top-line data, the study identified a...

Roche Holdings AG’s (OTC: RHHBY) Cobas SARS-CoV-2 Test has received U.S. authorization for testing individuals without symptoms or reasons to suspect a COVID-19 infection. “The high-throughput, highly sensitive Cobas SARS-CoV-2 Test under FDA Emergency Use Authorization...

Novavax, Inc (NASDAQ: NVAX) shares fell over 12% in the after-hours trading on Monday after closing almost 8.8% lower in regular trading. What Happened: The after-hours dip came as the Maryland-based company said that it is unlikely to seek emergency use authorization for its COVID-19 vaccine...

The U.S. Food and Drug Administration on Monday approved the emergency use of Pfizer Inc. (NYSE: PFE) and BioNTech SE’s (NASDAQ: BNTX) COVID-19 vaccine in adolescents aged between 12 to 15 years. What Happened: The FDA said it has amended the emergency use authorization (EUA) originally...

Ocugen Inc (NASDAQ: OCGN) shares soared 42.9% in the regular session and another 11% in the after-hours session on Thursday. What Happened: The shares surged following positive clinical data announced by a partner of Ocugen and a bullish stance taken by Roth Capital analyst Zegbeh Jallah who has a...

Johnson & Johnson (NYSE: JNJ) said Wednesday that its subsidiary Janssen Biotech Inc is requesting approval from the United States Food and Drug Administration for its single-dose COVID-19 vaccine candidate. What Happened: The multinational pharma company said in a statement that...

Moderna Inc's (NASDAQ: MRNA) COVID-19 vaccine has received the go-ahead from an advisory panel of the U.S. Food and Drug Administration, paving the way for the company to secure an emergency use authorization (EUA). What Happened: The Vaccines and Related Biological Products Advisory...