Regulation - Immunologicals, USA

Filter

Current filters:

ImmunologicalsUSA

Popular Filters

FDA approves Baxter/Halozyme’s HyQvia

FDA approves Baxter/Halozyme’s HyQvia

14-09-2014

The US Food and Drug Administration on Friday approved Baxter International’s and Halozyme Therapeutics’…

Baxter InternationalBiotechnologyHalozyme TherapeuticsHyQviaImmunologicalsRegulationUSA

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

Back to top