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FDA grants priority review to Takeda s BLA for dengue vaccine candidate

The US FDA has accepted and granted priority review to Takeda’s BLA for its investigational dengue vaccine candidate, TAK-003.

Gary dubinGlobal vaccine business unitDengue efficacy study

Takeda s Biologics License Application (BLA) for Dengue Vaccine Candidate (TAK-003) Granted Priority Review by U S Food and Drug Administration

OSAKA, Japan and CAMBRIDGE, Massachusetts - Takeda announced that the U.S. Food and Drug Administration has accepted and granted priority review of the Biologics License Application for TAK-003,. | November 23, 2022

American samoaUnited statesSri lankaPuerto ricoDominican republicUnited kingdomGary dubinRachel higginsJun saitoCenters for diseaseWorld health organizationTraveler healthDrug administrationInternational mediaData monitoring committeeExchange commission

Tetravalent Dengue Vaccine Candidate Granted Priority Review

The FDA has accepted for Priority Review the BLA for TAK-003, an investigational tetravalent dengue vaccine.

Gary dubinDrug administrationPriority reviewBiologics license applicationGlobal vaccine business unit

Innovative Dengue Vaccine Readies in Europe

QDENGA TAK-003 is a tetravalent dengue vaccine

United statesGary dubinEng eongLaura adamsSouth east asiaEuropean medicines agencyFlorida department of healthPrecision vaccinationsDengue tetravalent vaccineGlobal vaccine business unitWestern pacificFlorida departmentMiami dade countyOoi eng eongEmerging infectious diseases

Takeda Receives Positive CHMP Opinion Recommending Approval of Dengue Vaccine Candidate in EU and Dengue-Endemic Countries

Takeda Receives Positive CHMP Opinion Recommending Approval of Dengue Vaccine Candidate in EU and Dengue-Endemic Countries
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United statesSri lankaDominican republicJawa tengahGary dubinEng eongSouth east asiaCenters for diseaseWorld health organizationData monitoring committeeIndonesia national agency for drugExchange commissionTakeda pharmaceutical company limitedEuropean medicines agencyEuropean centre for disease preventionNatural resources defense council

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