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RSS FeedPosted by Michael Wonder on 15 Jun 2024
Novavax submits application to US FDA for updated protein based 2024-2025 formula COVID-19 vaccine
14 June 2024 - Novavax's updated JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3. ...
Posted by Michael Wonder on 09 Jun 2024
US FDA approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus vaccine for adults aged 50-59 at increased risk
7 June 2024 - Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of ...
Posted by Michael Wonder on 08 Jun 2024
Moderna files FDA application for the JN.1 targeting COVID-19 vaccine
7 June 2024 - Manufacturing is underway and doses of Moderna's Spikevax 2024-2025 formula will be ready to ship as ...
Posted by Michael Wonder on 08 Jun 2024
Updated COVID-19 vaccines for use in the United States beginning in fall 2024
7 June 2024 - The FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on 5 June 2024 to ...
Posted by Michael Wonder on 03 Jun 2024
Bavarian Nordic submits supplemental BLA seeking US FDA approval of freeze dried formulation of smallpox and mpox vaccine
31 May 2024 - Bavarian Nordic today announced the submission of a supplemental biologics license application to the US FDA ...
Posted by Michael Wonder on 31 May 2024
Moderna receives US FDA approval for RSV vaccine mRESVIA
31 May 2024 - mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes ...
Posted by Michael Wonder on 15 May 2024
Dynavax provides regulatory update on sBLA for four dose Heplisav-B regimen for adults on haemodialysis in the US
14 May 2024 - Dynavax Technologies today provided a regulatory update for the Company's supplemental biologics license application to include ...
Posted by Michael Wonder on 12 May 2024
Moderna announces update on investigational RSV vaccine
10 May 2024 - US FDA has informed Moderna that due to administrative constraints, the agency will not complete its review ...
Posted by Michael Wonder on 01 May 2024
Bavarian Nordic initiates rolling submission of biologics license application with FDA for its Chikungunya vaccine candidate
29 April 2024 - Bavarian Nordic today announced that it has initiated the rolling submission process with the US FDA ...
Posted by Michael Wonder on 16 Apr 2024
GSK’s 5 in 1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA
16 April 2024 - Submission based on results from pivotal Phase III trial showing all primary outcomes met. ...
Posted by Michael Wonder on 16 Mar 2024
ImmVira's oncolytic product MVR-T3011 IT intratumoral injection receives FDA fast track designation for HNSCC treatment
15 March 2024 - ImmVira has recently announced that the US FDA has granted fast track designation for oncolytic virus product ...
Posted by Michael Wonder on 13 Feb 2024
CAN-3110 receives FDA fast track designation for treatment of recurrent high-grade glioma
13 February 2024 - Candel Therapeutics today announced that the US FDA granted fast track designation for CAN-3110 -- a first ...
Posted 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 ...