Apitope gets FDA orphan drug status for ATX-F8-117 to treat Haemophilia A patients
Haemophilia A is a rare chronic bleeding disorder, which leads to inadequate clotting of blood in response to any type of injury or surgery and about 30% of
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have granted paediatric clinical trial waivers to Shanton Pharma for its lead candidate SAP-001, easing the drug’s regulatory paths to approval.
The second successfully out-licensed biosimilar in the product pipeline is ABY-021, which is a humanized monoclonal antibody for treating immunological symptoms. The out-licensing partner is once again a