Discover the EMA's role in promoting safe medicine access in the EU. Learn about its responsibilities in drug evaluation, ...

The European regulator has recommended marketing approval for Ranluspec and Gotenfia after studies confirm their safety, ...

NEXSPIKE is Moderna’s third product to receive a positive CHMP opinion alongside Spikevax (COVID-19 Vaccine, mRNA) and ...

Hikma Pharmaceuticals closed down 0.9% after the company said CEO Riad Mishlawi would step down from his role. Shares in GSK, ...

As neurological conditions expose the limits of traditional clinical endpoints, Europe’s regulators are being pushed to ...

If finalized, the changes would reduce the scope of AI regulations for medical devices and include more provisions for rare ...

Moderna on Monday said that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the marketing authorization of mNexspike, a new Covid-19 vaccine. The committee's ...

This effort to accelerate development can be clearly seen in how the agency is approaching biosimilars. In October 2025, the FDA issued a guidance update indicating that “switching” studies — a trial ...

Guselkumab has received approval for moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.1The decision is supported by the ...

Incyte Announces European Commission Approval of Minjuvi® (tafasitamab) for the Treatment of Relapsed or Refractory ...

The field of Regulatory science ensures that medicines, vaccines, and health products are safe and effective for people to ...