The FDA has rejected Pharming’s application to expand the licence of Ruconest, for a use as prophylaxis for patients with the serious rare disease hereditary angioedema (HAE).
The FDA has approved Shire’s first antibody-based preventive treatment for the rare disease hereditary angioedema, raising hopes for blockbuster-level sales as the company prepares for a ta
It’s 2024, and in most clinical trials, data is still being moved from the EHR to the EDC manually – with employees reading data from one screen and typing it onto another.