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RSS FeedPosted by Michael Wonder on 03 Sep 2025
FDA accepts Shionogi’s ensitrelvir NDA as the first oral therapy for the prevention of COVID-19 following exposure
2 September 2025 - Shionogi announced the US FDA has accepted a new drug application for ensitrelvir fumaric acid, an investigational ...
Posted by Michael Wonder on 31 Aug 2025
Moderna receives US FDA approval for updated COVID-19 vaccines targeting LP.8.1 variant of SARS-CoV-2
27 August 2025 - Moderna today announced that the US FDA has approved the supplemental biologics license applications for the ...
Posted by Michael Wonder on 31 Aug 2025
Pfizer and BioNTech’s Comirnaty receives US FDA approval for adults 65 and older and individuals ages 5 through 64 at increased risk for severe COVID-19
27 August 2025 - The 2025-2026 COVID-19 vaccine formulation targets the SARS-CoV-2 sub-lineage LP.8.1, in line with FDA guidance to more ...
Posted by Michael Wonder on 01 Jun 2025
Moderna receives US FDA approval for COVID-19 vaccine mNEXSPIKE
31 May 2025 - mNEXSPIKE becomes Moderna's third FDA approved product. ...
Posted by Michael Wonder on 25 May 2025
Moderna files FDA application for the LP.8.1 targeting COVID-19 vaccine
23 May 2025 - Moderna today announced that it has submitted an application to the US FDA for review of its ...
Posted by Michael Wonder on 20 May 2025
US FDA approves BLA for Novavax's COVID-19 vaccine
19 May 2025 - Nuvaxovid is the only recombinant protein-based, non-mRNA COVID-19 vaccine available in the US. ...
Posted by Michael Wonder on 06 Apr 2025
Update on US FDA BLA for Novavax’s COVID-19 vaccine
2 April 2025 - Novavax can confirm that 1 April 2025, was the US FDA’s Prescription Drug User Fee Act date ...
Posted by Michael Wonder on 01 Sep 2024
FDA authorises updated Novavax COVID-19 vaccine to better protect against currently circulating variants
30 August 2024 - Today, the US FDA granted emergency use authorisation for an updated version of the Novavax COVID-19 vaccine ...
Posted by Michael Wonder on 22 Aug 2024
FDA approves and authorises updated mRNA COVID-19 vaccines to better protect against currently circulating variants
22 August 2024 - Today, the US FDA approved and granted emergency use authorisation for updated mRNA COVID-19 vaccines (2024-2025 formula) ...
Posted by Michael Wonder on 15 Jun 2024
Novavax submits application to US FDA for updated protein based 2024-2025 formula COVID-19 vaccine
14 June 2024 - Novavax's updated JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3. ...
Posted by Michael Wonder on 08 Jun 2024
Moderna files FDA application for the JN.1 targeting COVID-19 vaccine
7 June 2024 - Manufacturing is underway and doses of Moderna's Spikevax 2024-2025 formula will be ready to ship as ...
Posted by Michael Wonder on 08 Jun 2024
Updated COVID-19 vaccines for use in the United States beginning in fall 2024
7 June 2024 - The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on 5 June 2024 to ...
Posted by Michael Wonder on 19 Dec 2023
Texas makes a stand against big pharma’s Covid vaccines
19 December 2023 - On the last day of November Texas launched extraordinary legal proceedings that could have wide-ranging political ...
Posted by Michael Wonder on 04 Oct 2023
FDA authorises updated Novavax COVID-19 vaccine formulated to better protect against currently circulating variants
3 October 2023 - Today, the US FDA amended the emergency use authorisation of the Novavax COVID-19 vaccine, adjuvanted for use ...
Posted by Michael Wonder on 21 Sep 2023
Supply and insurance issues snarl fall COVID-19 vaccine campaign for some
20 September 2023 - It has been just over a week since the US FDA and the US Centers for ...