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US FDA gives EUA to Moderna’s mRNA vaccine against COVID-19
expresspharma
December 21, 2020
Total of 200 million doses ordered by the US government to date, approximately 20 million doses will be delivered by the end of December 2020.
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US FDA declines approval for Novartis’ inclisiran
expresspharma
December 21, 2020
The drug regulator cited unresolved facility inspection issues for denying approval.
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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.
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Trial to Assess Pulsed Field Ablation System for AFib Receives FDA Conditional Approval
americanpharmaceuticalreview
December 18, 2020
FARAPULSE announced the U.S. Food and Drug Administration (FDA) conditionally approved the Company's Investigational Device Exemption (IDE) application to initiate its U.S. pivotal ADVENT trial to evaluate the safety and effectiveness of its ...
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FDA Approves Rare Pediatric Disease Designations for WP1066
americanpharmaceuticalreview
December 18, 2020
Moleculin Biotech announced the US Food and Drug Administration (FDA) has approved its request for a "Rare Pediatric Disease" designation for its drug candidate WP1066.
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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 ...
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FDA Authorizes Antigen Test as First OTC At-Home COVID-19 Diagnostic Test
americanpharmaceuticalreview
December 17, 2020
The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19.
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British American Tobacco’s COVID-19 vaccine candidate from gets US FDA nod for human trials
expresspharma
December 17, 2020
The enrolment for the study is expected to start shortly, with results likely by mid-2021, the company said.
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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.
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Iterum Therapeutics Submits NDA for Oral Sulopenem
americanpharmaceuticalreview
December 16, 2020
Iterum Therapeutics has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in patients with a ...