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RSS FeedPosted by Michael Wonder on 13 Dec 2019
Y-mAbs’ GD2-GD3 vaccine granted rare paediatric disease designation
12 December 2019 - Y-mAbs Therapeutics today announced that its GD2-GD3 vaccine has been granted a rare paediatric disease designation ...
Posted by Michael Wonder on 05 Nov 2019
FDA approves Fluzone High-Dose quadrivalent (influenza vaccine) for adults 65 years of age and older
4 November 2019 - Will be available in fall 2020, in time for the 2020-2021 flu season. ...
Posted by Michael Wonder on 17 Oct 2019
Complexity in assessing the benefit versus risk of vaccines: experience with rotavirus and dengue virus vaccines
17 October 2019 - The remarkable contribution of immunisation programs to public health is recognised by most people, including those who ...
Posted by Michael Wonder on 25 Sep 2019
FDA approves first live, non-replicating vaccine to prevent smallpox and monkeypox
24 September 2019 - The U.S. FDA announced today the approval of Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the ...
Posted by Michael Wonder on 17 Sep 2019
FDA accepts Merck’s biologics license application and grants priority review for V920, the company’s investigational vaccine for Ebola Zaire virus
17 September 2019 - Merck continues to expand investigational supply to support international Ebola outbreak response. ...
Posted by Michael Wonder on 09 Sep 2019
FDA reiterates the importance of vaccines such as the Measles, Mumps, and Rubella (MMR) vaccine
6 September 2019 - The U.S. continues to experience cases and outbreaks of measles, largely due to unvaccinated or under-vaccinated segments ...
Posted by Michael Wonder on 03 Sep 2019
Janssen announces U.S. FDA breakthrough therapy designation for investigational prophylactic vaccine for the prevention of respiratory syncytial virus in older adults
3 September 2019 - Janssen announced today that the U.S. FDA has granted breakthrough therapy designation for the Company's investigational ...
Posted by Michael Wonder on 20 Aug 2019
Moderna receives FDA fast track designation for Zika vaccine mRNA-1893
19 August 2019 - Moderna today announced that the U.S. FDA has granted fast track designation for its investigational Zika vaccine ...
Posted by Michael Wonder on 04 Aug 2019
Vas Narasimhan of Novartis: ‘we are not at all prepared for a pandemic’
1 August 2019 - The son of Indian immigrants read Greek philosophy and worked at McKinsey before joining a giant drug ...
Posted by Michael Wonder on 17 Jul 2019
Trump to order drive for improved flu vaccine
16 July 2019 - President Donald Trump is readying an executive order that would direct HHS to overhaul the development ...
Posted by Michael Wonder on 02 May 2019
First FDA approved vaccine for the prevention of dengue disease in endemic regions
1 May 2019 - The U.S. FDA announced today the approval of Dengvaxia, the first vaccine approved for the prevention of ...
Posted by Michael Wonder on 13 Mar 2019
Bavarian Nordic announces FDA delay in the review of the biologics license application for MVA-BN smallpox vaccine
11 March 2019 - Bavarian Nordic today announced that it has received information from the U.S. FDA that the review ...
Posted by Michael Wonder on 26 Feb 2019
Themis Bioscience receives FDA fast track designation for Chikungunya vaccine candidate
25 February 2019 - Themis Bioscience announced today that the United States FDA has granted fast track designation to the ...
Posted by Michael Wonder on 30 Jan 2019
Merck receives breakthrough therapy designation from FDA for V114, the company’s investigational 15-valent conjugate vaccine for the prevention of invasive pneumococcal disease, in infants, children, and adolescents
30 January 2019 - Merck today announced that V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation ...
Posted by Michael Wonder on 24 Jan 2019
FDA approves use of 0.5 mL dose of Fluzone Quadrivalent (influenza vaccine) in children as young as 6 months of age
23 January 2019 - The 0.5 mL dose is now approved for use in children 6 months through 35 months of ...