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Pfizer’s meningococcal B vaccine BLA accepted; gains priority review

Pfizer’s meningococcal B vaccine BLA accepted; gains priority review

15-08-2014

The US Food and Drug Administration has accepted for review the Biologics License Application for bivalent…

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Pfizer’s vaccine candidate bivalent rLP2086 gains “Breakthrough” status

Pfizer’s vaccine candidate bivalent rLP2086 gains “Breakthrough” status

20-03-2014

The US Food and Drug Administration has granted Breakthrough Therapy designation to pharma behemoth Pfizer’s…

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Leading Chinese hepatitis B vaccine makers stop production; Pfizer drug import halted

03-01-2014

China’s Food and Drug Administration announced on January 2 that the country’s three leading manufacturers…

Anti-viralsAntibiotics and Infectious diseasesAsia-PacificBioKangtaiChinaFluconazolePfizerPharmaceuticalRegulationVaccines

Updated EU labeling for Pfizer’s Prevenar 13

Updated EU labeling for Pfizer’s Prevenar 13

17-10-2013

The European Commission has approved updates to the Summary of Product Characteristics for US pharma…

EuropePfizerPharmaceuticalPrevenarRegulationVaccines

Pfizer gets EU approval for Prevenar 13 for adults aged 18-49

10-07-2013

US drug giant Pfizer (NYSE: PFE) has today received European approval for an expanded indication of its…

EuropePfizerPharmaceuticalPrevenarRegulationVaccines

Batch of mixed opinions from FDA advisory panels

21-06-2012

Advisory panels of the US Food and Drug Administration meeting yesterday came back with a mixture of…

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Expanded use for Pfizer’s Prevnar 13

03-01-2012

Following a previous US Food and Drug Administration advisory panel recommendation (The Pharma Letter…

North AmericaPfizerPharmaceuticalPrevnarRegulationVaccines

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