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RSS FeedPosted by Michael Wonder on 07 Feb 2024
GSK’s RSV vaccine, Arexvy, accepted under priority review in US for the prevention of RSV disease in adults aged 50-59 at increased risk
6 February 2024 - Application supported by positive results of a Phase 3 trial showing immune response and acceptable tolerability profile ...
Posted by Michael Wonder on 05 Feb 2024
Ultimovacs receives FDA fast track designation for UV1 cancer vaccine for the treatment of patients with unresectable mesothelioma
5 February 2024 - The designation was granted by the US FDA based on results from the randomised Phase II clinical ...
Posted by Michael Wonder on 20 Dec 2023
FDA grants priority review to Merck’s new biologics license application for V116, an investigational, 21 valent pneumococcal conjugate vaccine specifically designed to protect adults
19 December 2023 - The 21 serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in ...
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 28 Nov 2023
FDA fast track designation granted for Vaxinia trial program
28 November 2023 - FDA fast track designation for bile duct cancer granted for CF33-hNIS (Vaxinia) MAST clinical program. ...
Posted by Michael Wonder on 10 Nov 2023
FDA approves first vaccine to prevent disease caused by chikungunya virus
9 November 2023 - Today, the US FDA approved Ixchiq, the first chikungunya vaccine. ...
Posted by Michael Wonder on 02 Nov 2023
The FDA and Moderna’s cosy relationship: how lax rules enable a revolving door culture
1 November 2023 - After holding oversight roles for covid vaccines, two regulators from the US FDA went to work for ...
Posted by Michael Wonder on 24 Oct 2023
US Food and Drug Administration accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent
24 October 2023 - Potential to be the first and only self-administered flu vaccine. ...
Posted by Michael Wonder on 21 Oct 2023
FDA approves Penbraya, the first and only vaccine for the prevention of the five most common serogroups causing meningococcal disease in adolescents
20 October 2023 - The FDA’s decision is based on data from Phase 2 and Phase 3 trials, which demonstrated that ...
Posted by Michael Wonder on 12 Oct 2023
MimiVax granted fast track designation from FDA for SurVaxM for newly diagnosed glioblastoma
12 October 2023 - MimiVax announced today that the US FDA has granted fast track designation to MimiVax’s SurVaxM vaccine ...
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 ...
Posted by Michael Wonder on 07 Sep 2023
FDA may approve new Covid boosters by Friday as deaths spike
6 September 2023 - The FDA could approve new Covid-19 vaccine boosters as soon as Friday, NBC reported Wednesday, offering more ...
Posted by Michael Wonder on 21 Aug 2023
FDA approves first vaccine for pregnant individuals to prevent RSV in infants
21 August 2023 - Today, the US FDA approved Abrysvo (respiratory syncytial virus vaccine), the first vaccine approved for use in ...
Posted by Michael Wonder on 14 Aug 2023
Valneva announces PDUFA date extension for Chikungunya virus vaccine candidate
14 August 2023 – Valneva today announced that the US FDA has revised the PDUFA action date for the biologics ...