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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Dengvaxia vaccine approved for prevention of dengue in Europe

19 December 2018 - The European Commission has granted marketing authorization for Dengvaxia®, Sanofi’s dengue vaccine.  ...

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Emergent BioSolutions receives Health Canada approval of BioThrax (anthrax vaccine adsorbed)

17 December 2018 - Emergent BioSolutions today announced that Health Canada has approved the company’s new drug submission for its anthrax ...

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CSL's improved flu vaccine won't reach Australia until 2021

5 December 2018 - Australians may have to wait until 2021 for CSL's new cell-based quadrivalent influenza vaccine, which was ...

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