Amgen submits BLA for Infliximab biosimilar ABP 710 to FDA
Amgen Inc. has officially submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to ... Read More
FDA greenlights Amgen’s Nplate for pediatric immune thrombocytopenia
Amgen’s Nplate (romiplostim) has received US Food and Drug Administration (FDA) approval for treating pediatric patients with immune thrombocytopenia (ITP). This latest approval extends the ... Read More
EC approves Pelmeg: Mundipharma’s answer to chemotherapy-induced neutropenia
Mundipharma, a German pharmaceutical company, has achieved a significant milestone with the European Commission (EC)'s approval of Pelmeg, its pegylated biosimilar to Amgen’s Neulasta (pegfilgrastim). ... Read More
FDA approves once-weekly dosing for Amgen’s Kyprolis in multiple myeloma treatment
The United States Food and Drug Administration (FDA) has granted approval for a new once-weekly dosing regimen of Amgen's Kyprolis (carfilzomib) in combination with dexamethasone ... Read More
AstraZeneca and Amgen secure FDA breakthrough designation for asthma drug tezepelumab
In a significant advancement for asthma treatment, AstraZeneca, in partnership with Amgen, has received the coveted breakthrough therapy designation from the US Food and Drug ... Read More
EC grants expanded approval for Amgen’s BLINCYTO in pediatric acute lymphoblastic leukemia treatment
In a significant development for pediatric oncology, the European Commission (EC) has approved an expanded indication for Amgen’s BLINCYTO (blinatumomab) as a monotherapy treatment for ... Read More
Pfizer receives FDA approval for Nivestym, a Neutropenia biosimilar
Pfizer Inc. has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting approval for Nivestym (filgrastim-aafi), a biosimilar to Amgen's Neupogen ... Read More
Amgen and UCB resubmit BLA for EVENITY to transform osteoporosis treatment in postmenopausal women
Amgen, in collaboration with UCB, has announced the resubmission of the biologics license application (BLA) for their osteoporosis drug candidate, EVENITY (romosozumab), to the US ... Read More
FDA approves Amgen’s Repatha for heart attack and stroke prevention
In a significant advancement for cardiovascular disease management, Amgen's Repatha (evolocumab) has received approval from the U.S. Food and Drug Administration (FDA) to prevent heart ... Read More
Amgen’s Repatha proves effective in major cardiovascular outcomes study
Amgen Inc. has achieved a significant milestone with its cholesterol-lowering injection, Repatha (evolocumab), demonstrating a 20% reduction in heart attack and stroke risks among patients ... Read More