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RSS FeedPosted 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 ...
Posted by Michael Wonder on 15 Nov 2018
Merck begins rolling submission of licensure application for V920 (rVSV∆G-ZEBOV-GP) to U.S. FDA
13 November 2018 - V920 is the Company’s investigational vaccine for Ebola Zaire. ...
Posted by Michael Wonder on 31 Oct 2018
FDA grants priority review for Sanofi's dengue vaccine candidate
31 October 2018 - The United States FDA has accepted a biologics license application for Sanofi Pasteur's dengue vaccine. ...
Posted by Michael Wonder on 24 Oct 2018
Seqirus receives FDA approval of Afluria Quadrivalent (influenza vaccine) for people six months of age and older in the U.S.
17 October 2018 - Seqirus today announced the U.S. FDA has approved Afluria Quadrivalent (influenza vaccine) for use in people ...
Posted by Michael Wonder on 08 Oct 2018
Valneva announces FDA approval of accelerated Ixiario vaccination schedule
5 October 2018 - Valneva announced today that the U.S. FDA has approved an alternate Ixiaro immunisation schedule of two doses ...
Posted by Michael Wonder on 05 Oct 2018
FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old
5 October 2018 - The U.S. FDA today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) ...
Posted by Michael Wonder on 27 Sep 2018
Statement by FDA Commissioner on preparations for the upcoming flu season and vaccinations
27 September 2018 - This week marks the official start of “flu season” for 2018-2019. ...
Posted by Michael Wonder on 20 Sep 2018
Pfizer granted FDA breakthrough therapy designation for 20 valent pneumococcal conjugate vaccine for the prevention of invasive disease and pneumonia in adults aged 18 years ands older
20 September 2018 - Breakthrough therapy designation designed by FDA to expedite the development and review of drugs and vaccines which ...
Posted by Michael Wonder on 20 Jul 2018
Sellas receives fast track designation from FDA for galinpepimut-S for the treatment of patients with multiple myeloma
20 July 2018 - Sellas Life Sciences today announced that the U.S. FDA has granted fast track designation to the Company’s ...
Posted by Michael Wonder on 14 Jun 2018
FDA grants priority review to Merck’s supplemental biologics license application for Gardasil 9 in women and men ages 27 to 45 for the prevention of certain HPV-related cancers and diseases
13 June 2018 - Merck today announced that the U.S. FDA has accepted for review a new supplemental biologics license application ...
Posted by Michael Wonder on 05 May 2018
FDA grants PaxVax fast track designation for its Chikungunya vaccine
4 May 2018 - There are no licensed vaccines for chikungunya prevention and no specific treatments. ...
Posted by Michael Wonder on 23 Apr 2018
Pfizer granted FDA breakthrough therapy designation for Trumenba (meningococcal Group B vaccine) for the prevention of invasive meningococcal B disease in children aged 1 to 9 years
23 April 2018 - Pfizer today announced that Trumenba (meningococcal Group B vaccine) received breakthrough therapy designation from the U.S. FDA ...