Nivestym FDA approval : Pfizer’s Amgen neutropenia drug Neupogen biosimilar gets FDA nod
July 21, 2018 No Comment
Nivestym FDA approval : Pfizer has bagged approval from the US Food and Drug Administration (FDA) for Nivestym (filgrastim-aafi) – a biosimilar to Neupogen (filgrastim) for all eligible indications of the reference Amgen neutropenia drug. Filgrastim is indicated in the US for neutropenia treatment among others. Neutropenia or low blood neutrophils, is a condition in […]
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Ivosidenib FDA approval : The US Food and Drug Administration (FDA) has approved Agios Pharmaceuticals’ blood cancer drug TIBSOVO (ivosidenib) for the treatment of acute myeloid leukemia (AML). The ivosidenib FDA approval is for the treatment of adult patients whose condition is relapsed or refractory and who are prone to isocitrate dehydrogenase-1 (IDH1) mutation as […]
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An advisory committee of the United States Food and Drug Administration (FDA) has endorsed GSK malaria drug tafenoquine to be used as a single-dose for the treatment and relapse prevention of Plasmodium vivax (P. vivax) malaria in patients, aged 16 years and more. The Antimicrobial Drugs Advisory Committee (AMDAC) of the FDA had voted unanimously […]
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Amgen and UCB have resubmitted the biologics license application (BLA) of their investigational osteoporosis drug EVENITY (romosozumab) to the US Food and Drug Administration (FDA) for treatment of osteoporosis in postmenopausal women at high risk for fracture. A bone-forming monoclonal antibody, EVENITY is said to increase bone formation and simultaneously decrease bone resorption, in order […]
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Ironshore ADHD drug HLD200 : The US Food and Drug Administration (FDA) has accepted Ironshore Pharmaceuticals & Development’s resubmission of the New Drug Application (NDA) for HLD200 for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The company, which is a subsidiary of Highland Therapeutics, said that the FDA has set a Prescription Drug User […]
Continue reading …FDA lifts clinical hold on Advaxis’ Axalimogene Filolisbac, Durvalumab combo trial
July 15, 2018 No Comment
Advaxis revealed that the US Food and Drug Administration (FDA) has removed a previously imposed clinical hold on its Phase 1/2 trial of Axalimogene Filolisbac (AXAL) and Durvalumab combination. The early-stage trial by the New Jersey-based biotech company was assessing the drug combo for the treatment of advanced, recurrent or refractory cervical cancer and HPV-associated […]
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Tecovirimat FDA approval : Siga Technologies has bagged the US Food and Drug Administration (FDA) approval for its orally administered antiviral drug TPOXX (tecovirimat) for smallpox treatment. Siga Technologies had developed the small molecule drug Tecovirimat in conjunction with the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA). The […]
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Xtandi FDA approval : Astellas Pharma and Pfizer said that the US Food and Drug Administration (FDA) has expanded the approval of cancer drug Xtandi (enzalutamide) to be used for treatment of men with non-metastatic castration-resistant prostate cancer (CRPC). The earlier Xtandi FDA approval, which came in 2014, was for the treatment of men with […]
Continue reading …Mylan’s generic of Allergan's vaginal estrogen cream Estrace gets FDA nod
December 30, 2017 No Comment
Mylan has secured the US FDA approval for Estradiol Vaginal Cream USP, 0.01%, the generic version of Allergan’s vaginal estrogen cream – Estrace for the treatment of vulvar and vaginal atrophy. Following the approval of the vaginal estrogen cream, Mylan has announced the launch of Estradiol Vaginal Cream in the US. A condition that normally […]
Continue reading …ViiV Healthcare secures Juluca FDA approval for virologically suppressed HIV-1
November 25, 2017 No Comment
Juluca FDA approval : ViiV Healthcare’s 2-drug regimen Juluca has secured approval from the US Food and Drug Administration (FDA) for the maintenance treatment of virologically suppressed human immunodeficiency virus type 1 (HIV-1) infection. The HIV drug regimen Juluca, which is intended to be taken as a single pill daily once, is a combination of […]
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Business News Today
- Fresh Del Monte Produce begins operations at fresh cut plant in Yokohama
- Carlsberg, Marston’s to create Carlsberg Marston’s Brewing Company in UK
- FRP wraps up Carluccio’s sale to Boparan Restaurant Group
- GE to provide turbines for POWERICA’s Rajkot and Khambaliya wind farms
- KKR to invest $150m in Reliance’s digital services business Jio Platforms
- Rosatom fully commissions Akademic Lomonosov floating nuclear power plant
- Southern Power buys majority stake in Beech Ridge II Wind Facility from Invenergy
- Greenleaf Foods expands frozen portfolio with Field Roast Plant-Based Nuggets
- Popcornopolis rolls out Americorn Popcorn at Sam’s Club
- Winkler Wholesale Grocers selects ShopHero as ecommerce provider
