EMA CHMP recommends marketing authorisation for Novartis’ PNH treatment
This endorsement is a significant step towards the availability of Fabhalta for PNH patients in Europe. The positive opinion is based on data from two Phase III clinical
This endorsement is a significant step towards the availability of Fabhalta for PNH patients in Europe. The positive opinion is based on data from two Phase III clinical
This development marks the first nonsteroidal medication authorised to treat DMD patients with all genetic variants of a rare neurological disorder. A histone deacetylase (HDAC) inhibitor, Duvyzat can
EVO756 is a highly selective small molecule antagonist targeting mas-related G-protein coupled receptor X2 (MRGPRX2), a receptor implicated in various inflammatory conditions. This partnership builds on a previous
This kinase inhibitor is indicated to be used in combination with chemotherapy in adult patients with newly diagnosed Ph+ ALL. The approval was based on the treatment regimen
The acquisition is a significant step in AstraZeneca’s strategy to transform cancer treatment by offering more targeted therapies as alternatives to traditional treatments like chemotherapy and radiotherapy. RCs,
Abecma is a B-cell maturation antigen (BCMA)-targeted chimeric antigen receptor (CAR)-T cell immunotherapy. The ODAC validated the favourable benefit/risk profile of the therapy based on findings from the Phase
EQT Life Sciences and Nextech Invest jointly led the financing round with contributions from new US-based investors, Frazier Life Sciences and Deep Track Capital. Existing investors including Andera
The allogeneic CAR-T product candidate is being developed in partnership with Roche for relapsed/refractory multiple myeloma (RRMM). P-BCMA-ALLO1 targets the B-cell maturation antigen (BCMA) and is enriched with
The submission is scheduled for mid-2024, following constructive pre-submission meetings with EU regulatory authorities. The company also plans to engage with the US Food and Drug Administration (FDA)
A dual-acting IL-23 inhibitor, TREMFYA acts on both IL-23 and CD64 to potentially provide relief for patients. The sBLA is based on the data from the Phase III