While both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have released guidance on the ...

The PDCO’s positive opinion is based on PolTREG’s original preTreg clinical trial protocol initiated in October 2024, which enrolled children aged 6–16 years in Stage 1 type 1 diabetes. In its ...

A recent study by the University of Turku and the University of Helsinki in Finland and the Finnish Social Insurance ...

A recent study by the University of Turku and the University of Helsinki in Finland and the Finnish Social Insurance Institution Kela reveals that the average duration of ADHD medication for children ...

Moleculin Biotech's Q1 2025 earnings call highlights Phase 3 MIRACLE trial progress, EU regulatory signoff, patient enrollment milestones, and funding needs.

Experts say the European Vulnerability Database, or EUVD, should be a good resource, but only if ENISA manages to maintain it properly.

The EU's General Court annulled on Wednesday a European Commission decision not to disclose text messages Commission ...

Some U.S. biotech companies are considering moving early-stage trials of new medicines outside the United States as worry ...

The European drugs regulator said on Thursday its safety panel has confirmed suicidal thoughts as a side effect of ...

The EMA has recommended extensions to the marketing authorizations for Adcetris, used to treat Hodgkin lymphoma, and ...

But it doesn’t take a SpaceX-level engineer to understand that the Office of Government Ethics — an agency few Americans know by name, but whose unchecked power casts a long shadow over our ...