The EU is testing a groundbreaking “all-in-one” process for reviewing requests to conduct combined drug and diagnostic trials via a single application for coordinated assessment.
Sponsors planning to run multinational combined studies in the EU that involve both the clinical trials of medicines and the...
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.
Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.
