J&J’s filing is based on results from the phase 3 AQUILA trial. Among 390 patients with high-risk smoldering multiple myeloma ...

The European Medicines Agency has revealed a list of five cities that are preferred as its new location by staff after Brexit, following warnings of a public health disaster if EU leaders pick the ...

About AVT23 AVT23 is a monoclonal antibody and proposed biosimilar to Xolair ® (omalizumab). AVT23 is an investigational compound and has not received regulatory approval in any country. Biosimilarity ...

Patient involvement in health policy is a patchwork across the EU. Putting the lived experience front and centre of policy-making was prioritised at a recent high-level policy event organised by the ...

In 2023/24, the EU launched the Critical Medicines Alliance, while the European Medicines Agency has launched a “solidarity ...

The European Commission (EC) will decide in approximately two months. Last month, Novartis released new data from the ALITHIOS open-label extension study. Data show first-line Kesimpta (ofatumumab ...

today announced the submission of a Type II Variation to the European Medicines Agency (EMA) for vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR ...

Astellas to withdraw European marketing authorization application for avacincaptad pegol to treat GA secondary to AMD: Tokyo Tuesday, October 29, 2024, 13:00 Hrs [IST] Astellas Ph ...

Interim analysis for Study 1 of Essential3 Phase 3 program for ulixacaltamide in essential tremor (ET) confirmed for Q1 2025; NDA filing ...

Bayer has submitted an EMA application for darolutamide combined with ADT for metastatic hormone-sensitive prostate cancer. The Phase 3 ARANOTE trial showed darolutamide with ADT reduced ...

− Type II Variation Submission Based on the Positive HELIOS-B Phase 3 Study in which Vutrisiran Significantly Reduced the Risk of Death and Cardiovascular Events Relative to Placebo – "Today ...

Vutrisiran treatment leads to a decrease in serum vitamin A levels. Supplementation of approximately, but not exceeding, 2500 IU to 3000 IU vitamin A per day is advised for patients taking vutrisiran.