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FDA modifies Tekmira's TKM-Ebola clinical hold to partial hold

FDA modifies Tekmira's TKM-Ebola clinical hold to partial hold

08-08-2014

Canadian RNA interference (RNAi) therapeutics developer Tekmira Pharmaceuticals revealed yesterday that…

Anti-viralsEbolaMicrobiologyPharmaceuticalRegulationResearchTekmira PharmaceuticalsTKM-EbolaUS Food and Drug AdministrationUSA

US Senators call for immediate release of guidance on biosimilar drugs

US Senators call for immediate release of guidance on biosimilar drugs

06-08-2014

US Senators Lamar Alexander (Republican, Tennessee) and Orrin Hatch (Rep, Utah) have led colleagues in…

BiosimilarsGenericsPoliticsRegulationUS Food and Drug AdministrationUSA

Newly-approved drugs have one in three chance of black box warning or withdrawal

Newly-approved drugs have one in three chance of black box warning or withdrawal

05-08-2014

Newly-approved drugs have a one in three chance of acquiring a black box warning, or being withdrawn…

Boxed warningCassie FrankPharmaceuticalPharmaceutical industryPublic CitizenRegulationUS Food and Drug AdministrationUSA

US and European orphan status for AbbVie’s glioblastoma candidate

US and European orphan status for AbbVie’s glioblastoma candidate

04-08-2014

Both the European Medicines Agency and the US Food and Drug Administration have granted orphan drug designation…

AbbVieABT-414Brain tumorEuropeGlioblastoma multiformeMarkets & MarketingOncologyPharmaceuticalRare diseasesRegulationUS Food and Drug AdministrationUSA

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

Actavis files for generic version of Acorda’s Ampyra

Actavis files for generic version of Acorda’s Ampyra

27-06-2014

US biotech firm Acorda Therapeutics has been advised that Ireland-headquartered generics major Actavis…

Acorda TherapeuticsActavisAmpyraGenericsHealth Medical PharmaMedicinePharmaceutical sciencesPharmacologyRegulationUS Food and Drug AdministrationUSA

US FDA grants Valeant approval for Jublia NDA

US FDA grants Valeant approval for Jublia NDA

09-06-2014

Canadian drugmaker Valeant Pharmaceuticals International’s US subsidiary has received approval from…

CanadaDermatologicalsefinaconazoleJubliaPharmaceuticalRegulationUS Food and Drug AdministrationValeant Pharmaceuticals

Boehringer Ingelheim’s volasertib granted orphan drug designation for AML

Boehringer Ingelheim’s volasertib granted orphan drug designation for AML

17-04-2014

The US Food and Drug Administration and the European Commission have granted German family-owned drug…

Boehringer IngelheimEuropeGermanyHealth Medical PharmaMajorMedicineOncologyPharmaceuticalPharmacologyRegulationUS Food and Drug AdministrationUSAvolasertib

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ImmunoGen

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