Browsing Tag
Amgen
62 posts
CANDOR clinical trial results : Amgen’s Kyprolis extends PFS in multiple myeloma patients
CANDOR clinical trial results : Amgen said that a phase 3 study assessing Kyprolis (carfilzomib) in combination with…
September 13, 2019
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)…
December 18, 2018
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…
December 16, 2018
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,…
November 25, 2018
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…
October 2, 2018
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…
September 9, 2018
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…
August 30, 2018
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…
July 21, 2018
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…
July 15, 2018
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…
December 9, 2017