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AbbVie Receives U.S. FDA Approval of Supplemental New Drug Application for VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without Ribavirin in Genotype 1b Chronic Hepatitis C Patients with Compensated Cirrhosis

New Combinationpipeline review2016-04-26 17:30 Read   183

AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the use of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh A).

U.S. Food and Drug Administration Approves Gilead’s Second TAF-Based Single Tablet Regimen Odefsey® (Emtricitabine, Rilpivirine, Tenofovir Alafenamide) for the Treatment of HIV-1 Infection

New CombinationGilead Sciences2016-03-03 14:33 Read   296

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Odefsey® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients.

FDA approves new Kyprolis® (carfilzomib) combination therapy for the treatment of patients with relapsed or refractory multiple myeloma

New CombinationAmgen2016-01-27 09:01 Read   155

Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) of Kyprolis® (carfilzomib) for Injection in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.

FDA approves new treatment for HIV

New CombinationFDA2015-11-06 10:56 Read   343

The U.S. Food and Drug Administration today approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

Novartis receives EU approval for Tafinlar and Mekinist, first combination approved for patients with aggressive form of melanoma

New CombinationPharmacodia.com2015-09-01 00:00 Read   716

Novartis today announced that the European Commission has approved the combination of Tafinlar? (dabrafenib) and Mekinist? (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.