Tag: Amgen
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 ... Read More
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 ... Read More
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 ... Read More
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 ... Read More
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) ... Read More
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) ... Read More
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 ... Read More
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 ... Read More
Amgen’s Parsabiv gets EC approval for treating SHPT
American biopharma company Amgen’s Parsabiv drug has been approved by the European Commission for treating secondary hyperparathyroidism. Secondary Hyperparathyroidism (sHPT) is a serious and chronic ... Read More