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 ...

announced today that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar candidate to Prolia® and Xgeva® (denosumab).

China's virtual monopoly on the supply of many APIs could be dangerous for the security of medicine supply to Western ...

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 ...

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 ...

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.