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） ...

Tempest Therapeutics (TPST) announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track Designation, FTD, to amezalpat, ...

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

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.

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

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

Omeros Corporation (Nasdaq: OMER) today announced two presentations that will be featured at the 2025 Tandem Meetings – the ...

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 ...

A new drug reimbursement principle is seen as a significant departure from value-based pricing. Despite concerns, the new pricing system could increase the availability of some orphan drugs by 35 per ...