Fast Track Designation highlights potential of amezalpat to address unmet need for patients with HCC Amezalpat builds ...

近日，吉美瑞生再生医学集团（Regend Therapeutics）宣布， 美国食品药品监督管理局（FDA）已授予其气道基底层干细胞产品Pulmovinci孤儿药认定（Orphan Drug Designation, ODD） ...

Amezalpat received fast track designation from the FDA for the treatment of patients with hepatocellular carcinoma.

Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, today announced that the U.S. Food ...

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) and rare paediatric disease designation ...

Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment ...

Ariceum Therapeutics, a private biotech company based in Berlin, has announced that the US Food and Drug Administration (FDA) ...

The ORPHAN Cures Act (HR 946), a bipartisan bill that removes barriers to treating and curing rare diseases, was reintroduced in the US House of Representative last week.

Moleculin Biotech (MBRX) has received first country regulatory approval in Europe to begin recruiting for its Phase 3 pivotal trial protocol ...