BioCryst gets FDA fast track status for BCX4161 to treat Hereditary Angioedema
The Fast Track designation process of the FDA is designed to facilitate the development and expedite the review and approval of drugs intended to treat serious or life
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.
Hypoparathyroidism is a rare endocrine disorder characterized by insufficient levels of parathyroid hormone, or PTH. Natpara, a bioengineered replica of human PTH, is expected to be available in
Prevenar 13 is currently approved in Europe for the prevention of invasive pneumococcal disease (IPD) in the same population. he CHMP’s positive opinion will now be reviewed by