CARDIFF, UK / ACCESS Newswire / February 12, 2025 /Biodexa Pharmaceuticals PLC. (NASDAQ:BDRX), a clinical-stage ...

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 ...

Amezalpat has been granted FDA fast track designation as treatment for 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.

CARDIFF, UK / ACCESS Newswire / February 12, 2025 / Biodexa Pharmaceuticals PLC. (NASDAQ:BDRX), a clinical-stage biopharmaceutical company developing a pipeline of innovative products for the treatmen ...

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 ...

Ariceum Therapeutics, a private biotech company based in Berlin, has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its proprietary ...

The ORPHAN Cures Act (HR 946), a bipartisan bill that removes barriers to treating and curing rare diseases, was reintroduced ...

Ersodetug, a novel, fully human monoclonal antibody for the treatment of hyperinsulinism (HI), receives Breakthrough Therapy Designation and ...

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 ...