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Amgen seeks FDA approval for infliximab biosimilar ABP 710

Amgen seeks FDA approval for infliximab biosimilar ABP 710

Amgen has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to Johnson & Johnson’s REMICADE (infliximab). ABP 710 is being studied as a biosimilar candidate to infliximab, which is an anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody. Infliximab has approval in several regions […]

Amgen scores pediatric FDA approval for Nplate in immune thrombocytopenia

Amgen’s Nplate (romiplostim) has been approved by the US Food and Drug Administration (FDA) for the treatment of pediatric patients with immune thrombocytopenia (ITP). The latest Nplate FDA approval is for patients of one year of age and older who have ITP for at least six months and who showed insufficient response to corticosteroids, immunoglobulins […]

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EC approves Mundipharma’s Neulasta biosimilar Pelmeg for neutropenia

Pelmeg EU approval : The European Commission (EC) has approved German pharma company Mundipharma’s Pelmeg, a pegylated version of granulocyte-colony stimulating factor (G-CSF) and also a biosimilar to Amgen’s neutropenia medication – Neulasta (pegfilgrastim). Pelmeg EU approval for Neutropenia The approval for Pelmeg is for its use as a treatment to bring down the duration […]

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FDA approves new dosing option for Amgen blood cancer drug Kyprolis

The US Food and Drug Administration (FDA) has approved a weekly once dosing option for Amgen blood cancer drug Kyprolis (carfilzomib) in combination with dexamethasone (once-weekly Kd70) for patients having relapsed or refractory multiple myeloma. The prescribing information has been expanded to include a new weekly once dosing of 70 mg/m2 of KYPROLIS. Approval for […]

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AstraZeneca, Amgen asthma drug tezepelumab secures FDA breakthrough designation

UK biopharma company AstraZeneca and Amgen have secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for their asthma drug tezepelumab. The FDA breakthrough therapy designation for tezepelumab is for the treatment of patients with severe asthma, without an eosinophilic phenotype, who are administered inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids […]

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Amgen blood cancer drug BLINCYTO scores EC approval in pediatric patients

The European Commission (EC) has approved an expanded indication for Amgen blood cancer drug BLINCYTO (blinatumomab) as monotherapy for the treatment of certain form of acute lymphoblastic leukemia (ALL) in pediatric patients aged one year or older. The pediatric approval of BLINCYTO is for the treatment of patients with Philadelphia chromosome-negative (Ph-) CD19 positive B-cell […]

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Nivestym FDA approval : Pfizer’s Amgen neutropenia drug Neupogen biosimilar gets FDA nod

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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Amgen, UCB resubmit BLA of EVENITY osteoporosis drug to FDA

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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Amgen cholesterol drug Repatha bags FDA approval for preventing heart attack and stroke

Repatha FDA approval news : Repatha (evolocumab), the Amgen cholesterol drug has bagged the approval from the US Food and Drug Administration (FDA) for the prevention of heart attacks, strokes and coronary revascularizations in heart disease patients. The Amgen cholesterol injection is a human monoclonal antibody which has been designed to block the activities of […]

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Amgen cholesterol injection Repatha reduces heart attack, stroke chances

Amgen cholesterol injection Repatha (evolocumab) has been demonstrated to have cut heart attack and stroke risk by 20% in a phase 3 cardiovascular outcomes study featuring 27,564 patients with heart diseases. Amgen Cholesterol Trial for Repatha Cholesterol Injection During the trial, it was proven that by maximum reduction of low-density lipoprotein cholesterol (LDL-C) levels (bad cholesterol) […]

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