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RSS FeedPosted by Michael Wonder on 17 Jul 2025
US FDA approves GSK’s Shingrix in a pre-filled syringe presentation
17 July 2025 - Pre-filled syringe presentation offers a convenient administration option to health care professionals. ...
Posted by Michael Wonder on 15 Jul 2025
US FDA accepts application to review expanded use of GSK’s RSV vaccine, Arexvy, for adults 18-49 at increased risk
14 July 2025 - FDA decision anticipated H1, 2026 ...
Posted by Michael Wonder on 15 Jul 2025
Moderna receives full US FDA approval for COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years at increased risk for COVID-19 disease
10 July 2025 - Spikevax is now approved for all adults aged 65 years and older, and individuals aged 6 ...
Posted by Michael Wonder on 14 Jun 2025
Moderna receives US FDA approval for RSV vaccine, mRESVIA, in adults aged 18–59 at increased risk for RSV disease
12 June 2025 - Expanded indication builds on existing US FDA approval of mRESVIA for adults aged 60 and older. ...
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 21 May 2025
Moderna provides update on BLA submission for combination vaccine against influenza and COVID-19
21 May 2025 - Moderna today announced that in consultation with the US FDA, the Company has voluntarily withdrawn the ...
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 24 Apr 2025
Latest update on US FDA BLA for Novavax's COVID-19 vaccine
23 April 2025 - We believe that our biologics license application is approvable based on conversations with the US FDA, ...
Posted by Michael Wonder on 10 Apr 2025
Arcturus Therapeutics receives US FDA fast track designation for the STARR mRNA vaccine candidate ARCT-2304 for pandemic influenza A virus H5N1
10 April 2025 - Arcturus Therapeutics today announced that the US FDA has granted fast track designation for the self-amplifying mRNA ...
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 Apr 2025
Bavarian Nordic receives US FDA approval of freeze dried smallpox and mpox vaccine
31 March 2025 - Bavarian Nordic today announced that the US FDA has approved the freeze dried formulation of Jynneos (smallpox ...
Posted by Michael Wonder on 27 Mar 2025
Chlamydia vaccine candidate granted fast track designation by the US FDA
26 March 2025 - The US FDA has granted fast track designation to Sanofi’s mRNA vaccine candidate for the prevention of ...
Posted by Michael Wonder on 16 Feb 2025
Bavarian Nordic receives US FDA approval of chikungunya vaccine for persons aged 12 and older
14 February 2025 - On track for commercial launch in the US in the first half of 2025. ...
Posted by Michael Wonder on 15 Feb 2025
Penmenvy, GSK’s 5 in 1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY
15 February 2025 - Broad serogroup coverage in one vaccine reduces injections to help improve vaccination rates and help protect ...