Europe – New clinical trial map launched in the EU
A new clinical trial map is now accessible from the public website of the Clinical Trials Information System (CTIS). The map is designed to provide patients...
Europe – First topical gene therapy treatment for dystrophic epidermolysis bullosa
EMA has recommended granting a marketing authorisation in the European Union (EU) for Vyjuvek (beremagene geperpavec) to treat wounds in patients of all ages with dystrophic epidermolysis...
Europe – Combination of cystic fibrosis medicines to treat patients with rare mutations
EMA’s human medicines committee (CHMP) has recommended extending the therapeutic indication of two medicines, Kaftrio (ivacaftor / tezacaftor / elexacaftor) and Kalydeco (ivacaftor) for the treatment of...
UK – mRESVIA RSV vaccine approved to protect patients aged 60 and over
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved an mRNA respiratory syncytial virus (RSV) vaccine (brand name mRESVIA) to protect patients aged...
Europe – Clinical investigation of medicinal products in the treatment of patients with acute...
The aim of the guideline is to provide guidance for the development of medicinal products for the treatment of Acute Respiratory Distress Syndrome (ARDS)...
UK – Amgen’s Blincyto recommended by NICE for new adult leukaemia indication
The health technology assessment agency has recommended in final draft guidance that the immunotherapy be used on the NHS in combination with chemotherapy to...
UK – NICE recommends pharmaand’s Rubraca for advanced ovarian cancer
The health technology assessment agency has recommended in final draft guidance that the drug be used on the NHS in England, Wales and Northern...
Europe – Review of transparency rules for the EU Clinical Trials Information System (CTIS)
EMA has opened a public consultation to review the Appendix, on disclosure rules, to the functional specifications for the EU portal and EU database to be audited for...
UK – NHS rolls out life-changing treatment offering ‘new hope’ for hundreds of children...
Hundreds of children with severe epilepsy will be able to benefit from a groundbreaking new treatment on the NHS that could significantly reduce their...
UK – Exceptions and modifications to the EU guidance on good pharmacovigilance practices that...
Exceptions and modifications document – updates (01 Jan 2025)
-Overall updates were made to the document to reflect changes to UK legislation implementing new arrangements...
