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RSS FeedPosted 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 ...
Posted by Michael Wonder on 10 Aug 2023
New COVID-19 vaccine and booster shots for this fall to be available by end of September
9 August 2023 - The first new COVID-19 vaccines updated for this fall season are now expected to be available by ...
Posted by Michael Wonder on 03 Aug 2023
US FDA approves Merck’s Ervebo (Ebola Zaire vaccine, live) for use in children 12 months of age and older
3 August 2023 - Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease. ...
Posted by Michael Wonder on 21 Jul 2023
Emergent BioSolutions receives US FDA approval of Cyfendus (anthrax vaccine adsorbed, adjuvanted), previously known as AV7909, a two dose anthrax vaccine for post-exposure prophylaxis use
20 July 2023 - Emergent has been delivering Cyfendus vaccine to the US Department of Health and Human Services since ...
Posted by Michael Wonder on 11 Jul 2023
Takeda withdraws US application for dengue vaccine candidate
11 July 2023 - Takeda said on Tuesday it was voluntarily withdrawing its application for its dengue vaccine candidate, following ...
Posted by Michael Wonder on 27 Jun 2023
AC Immune receives FDA fast track designation for anti-amyloid beta active immunotherapy, ACI-24.060, to treat Alzheimer’s disease
27 June 2023 - Initial PET data on amyloid plaque reduction in Alzheimer's disease expected H1, 2024. ...
Posted by Michael Wonder on 27 Jun 2023
GSK receives US FDA fast track designation for investigational vaccine against gonorrhoea
27 June 2023 - Currently there are no vaccines approved anywhere in the world for gonorrhoea, and antimicrobial resistance to ...
Posted by Michael Wonder on 24 Jun 2023
Pfizer and BioNTech submit applications to US FDA for Omicron XBB.1.5 adapted monovalent COVID-19 vaccine
23 June 2023 - The submissions reflect guidance from FDA and other major health authorities to provide COVID-19 vaccines better matched ...
Posted by Michael Wonder on 23 Jun 2023
Moderna files for FDA authorisation of its updated COVID-19 vaccine
22 June 2023 - Preliminary clinical data demonstrated a robust immune response by the company's XBB.1.5 monovalent vaccine against XBB descendent ...
Posted by Michael Wonder on 01 Jun 2023
US FDA approves Abrysvo, Pfizer’s vaccine for the prevention of respiratory syncytial virus in older adults
31 May 2023 - FDA’s decision is based on the data from the pivotal Phase 3 clinical trial in approximately 37,000 ...