Lead Story
FDA to replace animal testing with new approach methodologies
The US Food and Drug Administration (FDA) has announced plans to replace animal testing for monoclonal antibodies (MABs).
Industry news
EMA to address antimicrobial resistance risks from veterinary medicinal products
The European Medicines Agency (EMA) has published a new concept paper outlining plans to assess the risks of humans developing AMR from VMPs via the environment.
MHRA authorises new cancer treatment variation with significantly reduced administration time
On 30 April 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) authorised a new under-the-skin injection variation of nivolumab (OPDIVO). This offers a quicker administration of the treatment for eligible patients.
MHRA provides guidance to streamline safety communication
The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on safety communications to ensure that medicines, medical devices and other healthcare products reach ‘high standards of safety, quality and efficacy.’
Key milestone reached in African medicines regulation
A key milestone for medicines regulation in Africa has been reached with the first continental listing of five medicinal products by the African Medicines Regulatory Harmonisation (AMRH) Steering Committee.
