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

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

Incyte INCY announced that the FDA has approved its new drug, Zynyz (retifanlimab-dlwr), a PD-1 inhibitor, for treating a new ...

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 ...

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 ...

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

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

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 ...

The inspection was conducted by the Finnish Medicines Agency on behalf of EMA from March 10 to March 14 and it concluded with ...

Morningstar brands and products Company Portfolio ...

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 ...