The European Medicines Agency believes its plan to develop guidance for reporting and evaluating mechanistic models used for MIDD would also benefit from input from other regulatory agencies, such as those in the US, Japan and Canada.
The European Medicines Agency is seeking feedback on its plan to develop guidance that it hopes will set the standards...
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
