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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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Approval for Seqirus flu vaccine

15 January 2019 - Seqirus has announced European approval of its new cell-based quadrivalent influenza vaccine. ...

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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 ...

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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. ...

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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 ...

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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, ...

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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, ...

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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 ...

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