"The FDA's approval of Imdelltra marks a pivotal moment for patients battling [extensive-stage small cell lung cancer]," Dr.
The U.S. Food and Drug Administration approved on Tuesday Amgen's Bkemv, the first biosimilar to AstraZeneca's rare blood ...
Amgen’s Bkemv is the first interchangeable biosimilar to Soliris to treat certain rare diseases. The treatment of patients ...
"It's just one of the most dreadful cancers and so we needed a new solution," he said. Amgen's drug is called a bispecific T-cell engager, which is designed to redirect the immune system's T-cells ...
The Food and Drug Administration on Thursday granted accelerated approval to a new dual-acting drug from Amgen to treat small ... antibody to gain FDA approval in cancer, and the first in small ...
"The FDA's approval of ... chief scientific officer at drug maker Amgen, said in a company news release. "Imdelltra offers these patients who are in urgent need of new innovative therapies hope ...
Results from a mid-stage trial , opens new ... Amgen said it will need to complete its larger, pivotal trial in advanced small cell lung cancer to receive full FDA approval of the drug.
the FDA said. had small cell lung cancer. After chemotherapy and immunotherapy, with her cancer still spreading rapidly, she was accepted into the Amgen study and began getting infusions of the ...
【プレスリリース】発表日:2024年05月31日ゾルベツキシマブ FDAが承認再申請を受理- 承認された場合、米国でファーストインクラスの抗CLDN18.2モノクローナル抗体となる可能性あり -アステラス製薬株式会社(本社 : ...
The US Food and Drug Administration (FDA) has approved Amgen's Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) for the treatment of specific rare diseases.