Forbes

FDA Turns Down Fluvoxamine Emergency Use Authorization Request

The Food and Drug Administration denied an emergency use authorization for fluvoxamine as a SARS-CoV-2 antiviral. Fluvoxamine was proposed as a possible antiviral in 2021 due to its mechanisms of ...
Nasdaq

Twist Bioscience Reports Expanded Emergency Use Authorization For SARS-CoV-2 Sequencing Assay

(RTTNews) - Twist Bioscience Corporation (TWST) and Biotia have received expanded Emergency Use Authorization from the FDA for the SARS-CoV-2 Next-Generation Sequencing Assay for the qualitative ...
News Medical

Pfizer and BioNTech seek emergency use authorization for Omicron BA.4/5-adapted booster vaccine

In a recent statement, Pfizer and BioNTech announced filing an application to the United States (US) Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a severe acute ...
Business Wire

Quidel’s Sofia® SARS Antigen Test Receives Emergency Use Authorization for Screening Use With Serial Testing

SAN DIEGO--(BUSINESS WIRE)--Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, ...
Monthly Prescribing Reference

FDA Pulls Authorization for Bebtelovimab Due to Nonsusceptible SARS-CoV-2 Variants

Credit: Getty Images. The CDC Nowcast data show that as of last week the BQ.1 and BQ.1.1 subvariants accounted for more than 57% of COVID-19 cases. Bebtelovimab is currently not authorized for ...
Wichita Eagle

EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna’s COVID-19 mRNA Vaccine Targeting the SARS-COV-2 Variant JN.1

Moderna's updated COVID-19 mRNA vaccine will be available for the 2024-2025 vaccination season, pending a European Commission authorization decision CAMBRIDGE, MA / ACCESSWIRE / September 5, 2024 / ...
Seeking Alpha

EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna's COVID-19 mRNA Vaccine Targeting the SARS-CoV-2 Variant LP.8.1

Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European Commission authorization decision "The CHMP's positive opinion on our updated ...