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) ...

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

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

There have been continued calls to reform orphan drug legislation in the US and the EU, particularly the 40-year-old Orphan Drug Act and the European Union's 1999 Orphan Drug Regulation.

How can orphan drug manufacturers demonstrate value and improve access to drugs? In this first of two articles on the subject, Ewan Bennett outlines ways to achieve reimbursement in countries ...

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

Orphan Drugs Market Orphan Drugs Market Dublin, Jan. 22, 2025 (GLOBE NEWSWIRE) -- The "Orphan Drugs - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering.The ...

WAYNE, PA — Palvella Therapeutics, Inc. (Nasdaq: PVLA) announced the expansion of SELVA, its Phase 3 clinical trial of ...

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 ...