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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

FDA approves Merck’s Ragwitek for short ragweed pollen allergies

18-04-2014

The US Food and Drug Administration has approved US pharma giant Merck & Co’s Biological License Application…

ALK AbelloImmunologicalsMerck & CoNorth AmericaPharmaceuticalRagwitekRegulationUSA

US FDA approves Stallergenes’ allergy tablet Oralair

US FDA approves Stallergenes’ allergy tablet Oralair

02-04-2014

The US Food and Drug Administration has approved Oralair immunotherapy tablet from French allergen specialist…

ImmunologicalsOralairPharmaceuticalRegulationStallergenesUSA

Scancell granted orphan drug designation for melanoma drug

Scancell granted orphan drug designation for melanoma drug

17-02-2014

UK-based immunotherapy company Scancell has been granted orphan drug designation for its SCIB1 ImmunoBody…

ImmunologicalsOncologyPharmaceuticalRegulationScancellSCIB1UKUSA

FDA advisory panel backing for Merck/ALK ragweed allergy immunotherapy Ragwitek

FDA advisory panel backing for Merck/ALK ragweed allergy immunotherapy Ragwitek

28-01-2014

The US Food and Drug Administration’s Allergenic Products Advisory Committee has voted that the available…

Alk-AbelloImmunologicalsMerck & CoNorth AmericaPharmaceuticalRagwitekRegulationUSA

Veloxis Pharma submits NDA for Envarsus in kidney transplant recipients

30-12-2013

Denmark’s Veloxis Pharmaceuticals has submitted a New Drug Application to the US Food and Drug Administration…

EnvarsusImmunologicalsLCP-TacroNorth AmericaPharmaceuticalRegulationUSAVeloxis Pharmaceuticals

ALK and Merck Co’s grass allergy tablet finally reaches FDA committee

ALK and Merck Co’s grass allergy tablet finally reaches FDA committee

10-12-2013

The US Food and Drug Administration Allergenic Products Advisory Committee will review US pharma giant…

ALK AbelloImmunologicalsMerck & CoPharmaceuticalRegulationUSA

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

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