Inc.收到美国食品药品监督管理局（以下简称“FDA”）的通知，BL-M11D1（CD33-ADC）用于治疗复发或难治性急性髓系白血病患者的I期临床试验申请已获得 ...

It was previous approved as a single agent in CD33-positive AML patients aged over ... This and other data was enough to convince an FDA advisory committee to recommend the drug should be ...

So far, only one drug has been approved by the FDA: gemtuzumab ozogamicin (Mylotarg; Pfizer), a humanized mAb specific for CD33, conjugated to the cytotoxic drug calicheamicin, was approved in ...

PRGN-3006 targets CD33, which is highly overexpressed in myeloid ... drug designations by the US Food and Drug Administration (FDA). Precigen completed a phase 1 study in which PRGN-3006 was ...

The committee voted 6-1 that Mylotarg in combination with chemotherapy has a favourable risk-benefit profile for patients with newly-diagnosed CD33-positive AML. The FDA is not bound to follow its ...

Pfizer Inc’s (NYSE:PFE) Mylotarg is indicated for newly diagnosed CD33-positive AML in adults ... Vor Bio plans to approach the FDA to discuss a pivotal trial design for trem-cel + Mylotarg ...

Actinium is advancing its lead product candidate Actimab-A, a CD33 targeting therapeutic ... actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory ...

Actinium is advancing its lead product candidate Actimab-A, a CD33 targeting therapeutic ... actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory ...

Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, today announced it will participate at the 37th Annual Roth ...