In the USA, two New Drug Applications (NDA) for crinecerfont have been accepted by the US regulator, and will be considered under the Priority Review scheme. 1 July 2024
Johnson & Johnson has submitted for an additional approval for Tremfya (guselkumab) to treat adults with moderately to severely active Crohn's disease. 21 June 2024
In the USA, the Food and Drug Administration has announced the availability of a draft guidance for industry which could smooth the path for biosimilars develop 21 June 2024
A commercial stage biopharmaceutical R&D company, focused on the development of products that address the medical challenges in the therapeutic area of anti-infectives.