Blog
RSS FeedPosted by Michael Wonder on 23 Feb 2023
Moderna and Merck announce mRNA-4157/V940, an investigational personalised mRNA cancer vaccine, in combination with pembrolizumab, was granted breakthrough therapy designation by the FDA for adjuvant treatment of patients with high-risk melanoma following complete resection
22 February 2023 - Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial. ...
Posted by Michael Wonder on 21 Feb 2023
Icosavax granted FDA fast track designation for IVX-A12
21 February 2023 - Icosavax today announced the US FDA has granted fast track designation for IVX-A12, a bivalent respiratory syncytial ...
Posted by Michael Wonder on 21 Feb 2023
US FDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
21 February 2023 - US FDA has set an action date for August 2023. ...
Posted by Michael Wonder on 20 Feb 2023
FDA accepts Valneva’s chikungunya vaccine license application for priority review
20 February 2023 - Valneva today announced that the US FDA has completed a filing review of its biologics license ...
Posted by Michael Wonder on 30 Jan 2023
Moderna granted FDA breakthrough therapy designation for mRNA-1345, an investigational respiratory syncytial virus vaccine candidate
30 January 2023 - Designation based on positive topline data from the ConquerRSV Phase 3 pivotal efficacy trial, which demonstrated ...
Posted by Michael Wonder on 10 Jan 2023
Moderna considers price of $110-$130 for COVID-19 vaccine
9 January 2023 - Commercial price is similar to Pfizer’s plans for after government contracting ends. ...
Posted by Michael Wonder on 07 Jan 2023
US FDA accepts for priority review the supplemental biologics license application for Pfizer’s 20 valent pneumococcal conjugate vaccine in infants and children
6 January 2023 - If approved, the vaccine would provide the broadest serotype coverage of any pneumococcal conjugate vaccine in infants ...
Posted by Michael Wonder on 06 Jan 2023
Vaxcyte’s VAX-24 granted FDA breakthrough therapy designation for the prevention of invasive pneumococcal disease in adults
5 January 2023 - Breakthrough therapy designation for 24 valent investigational pneumococcal conjugate vaccine candidate based on positive topline proof of ...
Posted by Michael Wonder on 29 Dec 2022
US FDA accepts for review the biologics license application for Pfizer’s investigational pentavalent meningococcal vaccine candidate (MenABCWY) in adolescents
28 December 2022 - Pfizer today announced that the US FDA accepted for review a biologics license application for its investigational ...
Posted by Michael Wonder on 24 Dec 2022
Valneva completes BLA submission to US FDA for its single shot chikungunya vaccine candidate
23 December 2022 - Valneva today announces that it has completed rolling submission of the biologics license application to the ...
Posted by Michael Wonder on 13 Dec 2022
PharmaJet Partner Immunomic Therapeutics receives FDA fast track designation for pDNA vaccine for skin cancer
13 December 2022 - Vaccine exclusively delivered with the PharmaJet Stratis needle-free injection system. ...
Posted by Michael Wonder on 10 Dec 2022
Pfizer and BioNTech receive US FDA fast track designation for single dose mRNA based vaccine candidate against COVID-19 and influenza
9 December 2022 - Pfizer and BioNTech today announced the companies have received fast track designation from the US FDA ...
Posted by Michael Wonder on 08 Dec 2022
FDA authorises updated (bivalent) COVID-19 vaccines for children down to 6 months of age
8 December 2022 - Today, the US FDA amended the emergency use authorisations of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 ...
Posted by Michael Wonder on 07 Dec 2022
US backs delay to decision on COVID patent waiver extension
6 December 2022 - The United States on Tuesday urged delaying a decision on whether to waive patent protection for ...
Posted by Michael Wonder on 07 Dec 2022
US FDA accepts for priority review the biologics license application for Pfizer’s respiratory syncytial virus vaccine candidate for the prevention of RSV disease in older adults
7 December 2022 - If approved, RSVpreF would help address the substantial burden of RSV disease in individuals 60 years ...