Cardiol’s broad IP portfolio and regulatory pathway focus, including FDA and European Medicines Agency orphan designations, ...

In a similar manner, member states must now pool their resources to address their shared geoeconomic concerns. To achieve ...

is pleased to announce that the European Medicines Agency (the “EMA”) has granted Orphan Medicinal Product Designation for the Company’s ExoPTEN therapy, marking a significant step towards making this ...

Product development highlights Alvotech announced that the European Medicines Agency (EMA) accepted a Marketing Authorization ...

September 2024: authorization received from The European Medicines Agency to initiate the INVINCIBLE-3 Study in Europe. September 2024: authorization from the Swiss Medic and the Swiss Ethics ...

Positive results from completed Phase 2 study of mavorixafor in chronic neutropenia (CN) announced todayPivotal Phase 3 trial of mavorixafor in ...

The pharmaceutical industry’s approach to data integrity has been historically manual, leveraging physical documentation and ...

As the COVID-19 pandemic clearly demonstrated, health is an integral part of Europe’s security. That principle underpinned a ...

Continuing to advance the pipeline and remain on-track to engage with the FDA on TP-04 (Papulopustular Rosacea) and TP-05 ...

With more than 27 million doses distributed globally, no single sign reported in an adverse event is classified as more than ...

A major news story from Sanofi this month is that "The European Medicines Agency has approved Dupixent (dupilumab) to treat ...

With more than 27 million doses distributed globally, no single sign reported in an adverse event is classified as more than ...