Blog
RSS FeedPosted 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 05 Mar 2019
Teenager's meningococcal death prompts coroner to urge free B-strain vaccine
5 March 2019 - A coroner wants the Tasmanian Government to offer free meningococcal B strain vaccines for people younger ...
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 07 Feb 2019
Pfizer's best selling drug is actually a vaccine—and its price keeps increasing
5 February 2019 - Pfizer is perhaps best known as the maker of drugs such as Viagra. But the pharmaceutical ...
Posted by Michael Wonder on 01 Feb 2019
Public consultation – draft cost recovery implementation statement for listing medicines on the PBS and designated vaccines on the NIP
1 February 2019 - After consultations with industry representatives during 2018, the Department of Health is releasing the draft statement ...
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 ...
Posted by Michael Wonder on 22 Jan 2019
Sanofi UK marketing authorisation granted for Sanofi Pasteur’s trivalent influenza vaccine (split virion, inactivated) high dose (TIV high dose)
21 January 2019 - UK is the only European country where TIV high dose is approved. ...
Posted by Michael Wonder on 15 Jan 2019
Approval for Seqirus flu vaccine
15 January 2019 - Seqirus has announced European approval of its new cell-based quadrivalent influenza vaccine. ...
Posted by Michael Wonder on 15 Jan 2019
FDA approves expanded use of Adacel (Tdap) vaccine for repeat vaccination
14 January 2019 - First and only vaccine approved in the U.S. for repeat vaccination 8 years or more after the ...
Posted by Michael Wonder on 03 Jan 2019
ImmusanT secures fast track designation for lead therapeutic vaccine candidate Nexvax2 for patients with celiac disease
2 January 2019 - Nexvax2 has been designed to potentially restore immune tolerance to gluten in patients with celiac disease. ...
Posted by Michael Wonder on 29 Dec 2018
Emergent BioSolutions announces submission to FDA of application covering emergency use authorisation for NuThrax
28 December 2018 - Emergent BioSolutions announced today the submission of an application to the U.S. FDA for potential emergency use ...
Posted by Michael Wonder on 27 Dec 2018
FDA approves Vaxelis, Sanofi and MSD’s paediatric hexavalent combination vaccine
26 December 2018 - The U.S. FDA has approved Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, ...
Posted by Michael Wonder on 25 Dec 2018
Valneva awarded FDA fast track designation for Chikungunya vaccine candidate
21 December 2018 - Valneva announced today that the U.S. FDA has granted fast track designation for its chikungunya vaccine candidate, ...
Posted by Michael Wonder on 23 Dec 2018
Bavarian Nordic announces FDA acceptance and priority review of biologics license application for MVA-BN smallpox vaccine
21 December 2018 - Bavarian Nordic today announced that the U.S. FDA has accepted its Biologics License Application (BLA) for the ...