Europe – First therapy to treat two types of Niemann-Pick disease, a rare genetic...
EMA has recommended granting a marketing authorisation in the European Union (EU) for Xenpozyme (olipudase alfa), a therapy for the treatment of non-central nervous system (CNS)...
Europe – EMA validates application for Byondis’ trastuzumab duocarmazine
Byondis has announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for the company’s investigational next generation anti-HER2 antibody-drug...
UK – NICE recommends Koselugo for the treatment of neurofibromatosis type 1
NF1 is a debilitating genetic condition, which affects one in 4,000 individuals worldwide. In 30 to 50% of people with NF, plexiform neurofibromas tumours...
Europe – GSK’s RSV vaccine candidate recommended by CHMP for older adults
There are currently no vaccines available to help protect older adults from RSV, a common contagious virus characterised by several mild, cold-like symptoms. Although...
Europe – First gene therapy to treat severe haemophilia A
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Roctavian (valoctocogene roxaparvovec) for the treatment of severe haemophilia A in adults who...
Europe – New agreement places Northern Ireland regulation back in the UK
Regulation of human medicines in Northern Ireland now are the responsibility of the UK Medicines and Healthcare products Regulatory Agency (MRHA) under an changes...
Europe – EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
EMA’s safety committee (PRAC) has confirmed its recommendation to withdraw the marketing authorisations for amfepramone obesity medicines. This follows a re-examination of its previous recommendation of June 2022, which was...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Two new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended two medicines for approval at its May 2023 meeting.
The committee recommended granting a marketing...
Europe – EC authorisation granted to kidney disease treatment Kinpeygo
The European Commission (EC) has granted conditional marketing authorisation for Kinpeygo (budesonide) capsules for the treatment of primary immunoglobulin A nephropathy (IgAN).
The treatment involves...
Europe – Biosimilar medicines can be interchanged
EMA and the Heads of Medicines Agencies (HMA) have issued a joint statement confirming that biosimilar medicines approved in the European Union (EU) are interchangeable with their reference...