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Positive top-line Ph III results for Baxter’s BAX 855 in hemophilia A

Positive top-line Ph III results for Baxter’s BAX 855 in hemophilia A

21-08-2014

US drugmaker Baxter International has announced positive results from its Phase III pivotal clinical…

AdvateBAX 855Baxter InternationalHematologyPharmaceuticalRegulationResearch

FDA advisory panel backs Baxter’s HyQvia for primary immunodeficiency

FDA advisory panel backs Baxter’s HyQvia for primary immunodeficiency

01-08-2014

The Blood Products Advisory Committee of the US Food and Drug Administration has voted 15-1 that HyQvia…

Baxter InternationalBiotechnologyHalozyme TherapeuticsHyQviaImmunologicalsRegulationUS Food and Drug AdministrationUSA

FDA extends PDUFA date for Baxter and Halozyme’s HyQvia

21-05-2014

US drugmakers Baxter International and Halozyme Therapeutics revealed that the US Food and Drug Administration…

Baxter InternationalBiotechnologyHalozyme TherapeuticsHyQviaImmunologicalsRegulationUSA

Baxter’s Feiba gains FDA approval for prophylactic treatment of hemophilia A and B

Baxter’s Feiba gains FDA approval for prophylactic treatment of hemophilia A and B

20-12-2013

US drugmaker Baxter International has received approval from the US Food and Drug Administration for…

Baxter InternationalFeibaHematologyPharmaceuticalRegulation

Baxter files amended BLA to FDA for HyQvia for primary immunodeficiency

Baxter files amended BLA to FDA for HyQvia for primary immunodeficiency

02-12-2013

USA-based Baxter International has completed submission of an amended biologics license application to…

Baxter InternationalHalozyme TherapeuticsHyQviaImmunologicalsNorth AmericaPharmaceuticalRegulationUSA

FDA backs Baxter's Rixubis for hemophilia B; Breakthrough status for GSK's drisapersen

28-06-2013

The US Food and Drug Administration yesterday (June 27) approved Baxter International's (NYSE: BAX) Rixubis…

Baxter InternationaldrisapersenGlaxoSmithKlineNorth AmericaPharmaceuticalRare diseasesRegulationRixubis

News briefs: setbacks for B-MS hep C drug; Baxter's HyQ

02-08-2012

US drug major Bristol-Myers Squibb (NYSE: BMY) has suspended study drug administration in ongoing Phase…

Anti-viralsBaxter InternationalBMS-986094Bristol-Myers SquibbHyQImmunologicalsNorth AmericaPharmaceuticalRegulationResearch

Halozyme plunges as FDA call for more data on HyQ BLA

17-04-2012

USA-based Halozyme Therapeutics saw its shares plummet 24% to $8.56 by close of trading yesterday, after…

Baxter InternationalBiotechnologyHalozyme TherapeuticsHyQImmunologicalsNorth AmericaRegulation

EU Commission OKs Baxter Avian flu vaccine Vepacel; drops GSK probe

05-03-2012

US drugmaker Baxter International (NYSE:BAX) says that the European Commission has granted marketing…

Anti-viralsBaxter InternationalEuropeGlaxoSmithKlineLegalPharmaceuticalRegulationSynthonVaccinesVepacel

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