UK MHRA accepts to review RedHill’s marketing application for Bekinda
Bekinda (RHB-102) is a proprietary once-daily oral pill formulation of the antiemetic drug ondansetron. The UK MHRA has started the formal review process for the MAA on 30
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.