Amgen’s Bkemv is the first interchangeable biosimilar to Soliris to treat certain rare diseases. The treatment of patients ...
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 U.S. Food and Drug Administration approved on Tuesday Amgen's Bkemv, the first biosimilar to AstraZeneca's rare blood ...
Results from a mid-stage trial , opens new tab ... drugs. Amgen said it will need to complete its larger, pivotal trial in advanced small cell lung cancer to receive full FDA approval of the ...
"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 FDA approved Imdelltra more than three weeks ahead of its deadline, and based its decision on a trial showing the drug shrank tumors in 40% of patients who received it. Amgen will need to complete ...
The US FDA has approved Amgen's Bkemv as an interchangeable biosimilar to Soliris for the treatment of specific rare diseases ...
"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 ...
"The FDA's approval of Imdelltra marks a pivotal moment for patients battling [extensive-stage small cell lung cancer]," Dr. Jay Bradner, executive vice president of research and development and chief ...
Results from a mid-stage trial published last year in the New ... drugs. Amgen said it will need to complete its larger, pivotal trial in advanced small cell lung cancer to receive full FDA ...