The European Medicines Agency (EMA) has approved Moleculin Biotech’s clinical trial application (CTA) for a pivotal, ...

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

Reports of severe adverse events in some people who received the chikungunya vaccine have spurred regulators in Europe and ...

Adds nine additional countries to the Company’s ongoing pivotal Phase 3 trial; Authorization granted in all EU countries ...

Shares of the biotech fell around 15% on news the FDA is not only taking longer to review the drug, but will assemble an ...

A recent study reveals that the average duration of ADHD medication for children and adolescents is more than three years. However, reliable, controlled data on the safety of marketed ADHD medicines ...

New figures from European industry group EFPIA paint a stark picture of the growing divide in access to innovative medicines ...

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 ...

The decision was taken following a plenary meeting of the Pharmacovigilance Risk Assessment Committee (PRAC) on May 5, 2025 and is based on reports of 17 SAEs worldwide (including two deaths) in ...

Few areas of healthcare are as sensitive as cancer treatment. Each year, around 44,000 cancer tumours are diagnosed here.

Saint Herblain (France), May, 07 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) has started a review ...