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FDA requests CMC data on Lundbeck’s Carbella application

25-10-2014

Danish CNS drug specialist Lundbeck says that it has received a Complete Response Letter (CRL) from the…

CarbamazepineCarbellaLigand PharmaceuticalsLundbeckNeurologicalPharmaceuticalRegulationUSA

FDA backs added indication for GSK’s Promacta

FDA backs added indication for GSK’s Promacta

27-08-2014

The Food and Drug Administration has approved UK pharma giant GlaxoSmithKline’s supplemental New Drug…

GlaxoSmithKlineHematologyLigand PharmaceuticalsPharmaceuticalPromactaRare diseasesRegulationRevoladeUSA

FDA accepts Lundbeck NDA for IV carbamazepine

FDA accepts Lundbeck NDA for IV carbamazepine

10-03-2014

The US subsidiary of Danish CNS specialist Lundbeck says that the Food and Drug Administration has accepted…

CarbamazepineCarbellaFinancialLigand PharmaceuticalsLundbeckNeurologicalNorth AmericaPharmaceuticalRegulationUSA

GSK files for US approval for Promacta for severe aplastic anemia

GSK files for US approval for Promacta for severe aplastic anemia

02-03-2014

UK pharma giant GlaxoSmithKline has submitted a supplemental New Drug Application to the US Food and…

GlaxoSmithKlineLigand PharmaceuticalsNorth AmericaOncologyPharmaceuticalPromactaRare diseasesRegulationUSA

US FDA backs Pfizer’s hot flashes drug Duavee

US FDA backs Pfizer’s hot flashes drug Duavee

04-10-2013

Pfizer and partner Ligand Pharmaceuticals say that the US Food and Drug Administration has approved Duavee,…

bazedoxifeneDuaveeLigand PharmaceuticalsNorth AmericaPfizerPharmaceuticalRegulationWomen's Health

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