Whilst racking up 50 novel drug approvals, the FDA approved fewer than it did in 2023, when there were 55 greenlit to market. Conversely, the EMA’s 2024 figure of 46 was a step up from the 39 ...

Jon Walsh, founder, chief scientific officer, Unlearn, explains how regulators are clarifying best practices for integrating AI and digital twins into clinical research.

The approval is supported by strong preclinical data demonstrating MP1032's capacity to sustain muscle function.

The FDA had halted use in older adults while it investigated reports of side effects. The vaccine’s label now carries new ...

The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response ...

Drug manufacturers continue to submit regulatory documents to the FDA earlier than the EMA. The FDA received new drug licensing applications a median of 20 days earlier than the EMA, the study found.

Refer to the General Principles document for FDA and EMA’s recommendations on what to include in this request and the subsequent PSA processes. Questions about the program can be directed here.

The biggest difference between the FDA and EMA review processes is that the FDA uses outside experts for its advisory panels, while the EMA's CHMP is made up of regulators from each of the 27 member ...

The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have authorised AB Science’s confirmatory Phase III Study AB22007 trial of masitinib in treating metastatic ...

A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the period 2014-2016.

The FDA median review time amounted to 206 days compared while the EMA needed 379 days. The FDA was also faster when it came to drugs given orphan status — those medicines treating populations ...