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RSS FeedPosted 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. ...
Posted by Michael Wonder on 18 Jul 2024
Diakonos Oncology receives FDA fast track designation for pancreatic cancer dendritic cell vaccine
15 July 2024 - Diakonos Oncology announced today that the US FDA has granted fast track designation for the company’s unique ...
Posted by Michael Wonder on 18 Jun 2024
US FDA approves Capvaxive (pneumococcal 21 valent conjugate vaccine) for prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults
17 June 2024 - Capvaxive (V116) is specifically designed for adults and covers serotypes responsible for approximately 84% of invasive pneumococcal ...
Posted by Michael Wonder on 17 Jun 2024
Bavarian Nordic completes BLA submission to US FDA for its Chikungunya vaccine candidate
17 June 2024 - First regulatory submission completed for CHIKV VLP seeking approval of the vaccine candidate for immunisation against chikungunya ...