EMA committee issues positive opinion for Novartis’ lung cancer drug Zykadia
If Zykadia receives approval in the European Union (EU), it will be the first treatment option to address an unmet medical need for these patients. Zykadia is an
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 company said that TRPH 011 binds and neutralizes VEGFR-2/KDR and TIE 2 receptors simultaneously, resulting in sustained inhibition of tumor growth and angiogenesis. Angiogenesis is the formation
The trial evaluated the safety, tolerability and pharmacokinetics of OBE001 and betamethasone, a corticosteroid, when co-administered to healthy non-pregnant women. Betamethasone is administered to prevent respiratory distress syndrome