New ‘statement of policy’ directs US FDA to publish charts of its approval timeliness – using an outdated 180-day benchmark to make its approval speed look worse.
The final days of the Trump Administration have been marked by repeated conflict between the US Department of Health & Human Services and the Food & Drug Administration over the limits of the agency’s authority.
That turf war has played out via formal notices – like an effort to force FDA into a laborious process...
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Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022.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.
