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The health technology assessment agency has recommended in final draft guidance that the immunotherapy be used on the NHS in combination with chemotherapy to...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The health technology assessment agency has recommended in final draft guidance that the drug be used on the NHS in England, Wales and Northern...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...
USA – FDA alerts drug manufacturers to the risk of benzene contamination in certain...
FDA is evaluating the root cause of benzene contamination in certain drugs and alerting drug manufacturers to the risk of benzene contamination from drug...
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...
UK – Efanesoctocog alfa approved to prevent and treat bleeding in children and adults...
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 14 February 2025, approved efanesoctocog alfa (brand name Altuvoct) to be used to treat...
USA – FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and...
UK – Nemolizumab approved to treat prurigo nodularis and atopic dermatitis (eczema) for patients...
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 17 February 2025, approved the medicine nemolizumab (brand name Nemluvio) for the treatment of...
UK – Access, new active substance and biosimilar work sharing initiatives
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong...
