US FDA could revoke orphan designation or exclusivity if cost recovery requirements were not satisfied under bill unanimously passed by the House Energy and Commerce Committee.
A rare, but now well-known, loophole in the cost recovery pathway to orphan drug exclusivity would be closed under legislation unanimously passed by the House Energy and Commerce Committee.
The Fairness in Orphan Drug Exclusivity Act, sent to the full House of Representatives for consideration on 15 July, would...
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Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022.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.
