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Novo Nordisk gains FDA backing for new NovoSeven RT indication

Novo Nordisk gains FDA backing for new NovoSeven RT indication

09-07-2014

Danish diabetes care giant Novo Nordisk’s hemophilia treatment NovoSeven RT (coagulation factor VIIa…

HematologyNovo NordiskNovoSevenNovoSeven RTPharmaceuticalRare diseasesRegulationUSA

Geron leaps as FDA lifts partial hold on imetelstat trial

Geron leaps as FDA lifts partial hold on imetelstat trial

13-06-2014

US biotech Geron Corp's shares jumped around 27% to $3.31 in early afternoon trading yesterday after…

BiotechnologyGeron CorpHematologyimetelstatOncologyRegulationUSA

Biogen Idec’s Eloctate gains FDA approval

Biogen Idec’s Eloctate gains FDA approval

09-06-2014

The US Food and Drug Administration on Friday approved US biotech firm Biogen Idec’s Eloctate, antihemophilic…

Biogen IdecBiotechnologyEloctateHematologyRegulationSwedish Orphan BiovitrumUSA

FDA approves new indication for Bayer's Kogenate

12-05-2014

The US Food and Drug Administration has approved a new indication for German drug major Bayer's Kogenate…

BayerHematologyKogenate FSPharmaceuticalRegulationUSA

IQWiG finds added benefit for Novo Nordisk’s NovoEight not proven

23-04-2014

In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products…

GermanyHematologyNorthern EuropeNovo NordiskNovoEightPharmaceuticalPricingRegulation

US FDA clears Biogen Idec and SOBI’s Alprolix for hemophilia B

US FDA clears Biogen Idec and SOBI’s Alprolix for hemophilia B

31-03-2014

Marking a second regulatory hurdle for the breakthrough product, the US Food and Drug Administration…

AlprolixBenefixBiogen IdecBiotechnologyCSL LimitedHematologyNorth AmericaNovo NordiskPfizerRegulationSwedish Orphan BiovitrumUSA

Health Canada approves Biogen Idec’s long-acting Alprolix hemophilia B

Health Canada approves Biogen Idec’s long-acting Alprolix hemophilia B

21-03-2014

US biotech firm Biogen Idec has announced that Health Canada has approved Alprolix for the control and…

AlprolixBiogen IdecCanadaHematologyPharmaceuticalRegulation

FDA cites insufficient information in response to AMAG’s Feraheme application

FDA cites insufficient information in response to AMAG’s Feraheme application

23-01-2014

US drug company AMAG Pharmaceuticals (Nasdaq: AMAG) has received a complete response letter from the…

AMAG PharmaceuticalsFerahemeHematologyNephrology and HepatologyPharmaceuticalRegulationUSA

FDA approves Novo Nordisk’s Tretten to treat rare genetic clotting disorder

FDA approves Novo Nordisk’s Tretten to treat rare genetic clotting disorder

24-12-2013

The US Food and Drug Administration yesterday (December 23) approved Tretten, coagulation factor XIII…

HematologyNorth AmericaNovo NordiskNovoThirteenPharmaceuticalRare diseasesRegulationTretten

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

New Zealand funding plans for Tarceva and Revolade

New Zealand funding plans for Tarceva and Revolade

09-12-2013

Following a consultation, New Zealand’s Pharmaceutical Management Agency PHARMAC said this morning…

Asia-PacificGlaxoSmithKlineHematologyNew ZealandOncologyPharmaceuticalPricingRegulationRevoladeRocheTarceva

Benefits of Kogenate/Helixate NexGen outweigh risks, says EMA unit

Benefits of Kogenate/Helixate NexGen outweigh risks, says EMA unit

08-12-2013

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the…

BayerCardio-vascularCSL BehringCSL LimitedEuropeHelixateHematologyKogenatePharmaceuticalRegulation

US FDA delays Alprolix approval

US FDA delays Alprolix approval

02-12-2013

The US Food and Drug Administration (has extended the initial Prescription Drug User Fee Act date for…

AlprolixBiogen IdecBiotechnologyHematologyNorth AmericaRegulationSwedish Orphan BiovitrumUSA

Novo Nordisk’s NovoEight passes first stage of Japanese approval

Novo Nordisk’s NovoEight passes first stage of Japanese approval

18-11-2013

Danish insulin giant Novo Nordisk’s recombinant factor VIII product NovoEight (turoctocog alfa) has…

Asia-PacificHematologyNovo NordiskNovoEightPharmaceuticalRare diseasesRegulation

US FDA calls for further data on Biogen Idec’s Eloctate

US FDA calls for further data on Biogen Idec’s Eloctate

13-11-2013

Swedish Orphan Biovitrum has announced that its partner, US biotech major Biogen Idec, has received a…

Biogen IdecBiotechnologyEloctateHematologyNorth AmericaRegulationSwedish Orphan Biovitrum

US FDA approved Novo Nordisk hemophilia A drug

US FDA approved Novo Nordisk hemophilia A drug

16-10-2013

Novo Nordisk revealed this morning that the US Food and Drug Administration has approved its Biologics…

HematologyNorth AmericaNovo NordiskNovoEightPharmaceuticalRegulationturoctocog alfa

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Eleven Biotherapeutics

Eleven Biotherapeutics

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