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RSS FeedPosted 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 ...
Posted by Michael Wonder on 13 Jan 2025
GSK’s Shingrix new pre-filled syringe presentation accepted for review by US FDA
10 January 2025 - An FDA decision on the application is expected by 20 June 2025. ...
Posted by Michael Wonder on 22 Dec 2024
LimmaTech awarded FDA fast track designation for vaccine candidate against Staphylococcus aureus
19 December 2024 - LimmaTech Biologics announced today that the US FDA has granted fast track designation to LimmaTech’s multivalent ...
Posted by Michael Wonder on 12 Dec 2024
Two combination vaccine candidates for prevention of influenza and COVID-19 granted fast track designation in the US
11 December 2024 - Two Phase 1/2 clinical studies are ongoing to evaluate the safety profile and immune response induced by ...
Posted by Michael Wonder on 04 Dec 2024
Valneva submits label extension application for its Chikungunya vaccine, Ixchiq, to the US FDA
26 November 2024 - To potentially include adolescents and antibody persistence up to two years. ...
Posted by Michael Wonder on 23 Oct 2024
US FDA approves Pfizer’s RSV vaccine Abrysvo for adults aged 18 to 59 at increased risk for disease
22 October 2024 - Approval based on data from pivotal Phase 3 trial in adults at increased risk of lower ...
Posted by Michael Wonder on 17 Oct 2024
Valneva and LimmaTech awarded FDA fast track designation for tetravalent Shigella vaccine candidate S4V
16 October 2024 - Valneva and LimmaTech Biologics announced today that the US FDA has granted fast track designation to ...
Posted by Michael Wonder on 08 Oct 2024
The FDA approved a self-administered nasal spray for the flu. Here’s how it compares to the traditional flu shot.
6 October 2024 - The US FDA recently approved FluMist as a self or caregiver-administered nasal spray flu vaccine to prevent ...
Posted by Michael Wonder on 20 Sep 2024
FDA approves nasal spray influenza vaccine for self or caregiver administration
20 September 2024 - First influenza vaccine that does not need to be administered by a health care provider. ...
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 30 Aug 2024
Emergent BioSolutions’ Acam2000 (smallpox and mpox (Vaccinia) vaccine, live) receives US FDA approval for mpox indication
29 August 2024 - Emergent BioSolutions today announced that the US FDA has approved the supplemental biologics license application for the ...
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 13 Aug 2024
Bavarian Nordic announces FDA acceptance and priority review of the BLA for its Chikungunya vaccine
13 August 2024 - PDUFA target action date of 14 February 2025. ...