A revised indication, additional contraindications and strengthened monitoring requirements has been recommended for Lemtrada (alemtuzumab) following a review.
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A new bill is now effective in the UK which aims to improve regulation for medical devices and ensure patient safety, as well as allow hospitals to develop personalised medicines.
Dysport®, a therapy for spasticity in cerebral palsy patients has been granted a license update to treat children aged two years and older.
The current regulatory system for medical devices in the UK, as an EU member state, is complex enough without the uncertainties surrounding Brexit. In this article, legal advisor Paul Ranson reviews the current and forthcoming regimes and how Brexit may impact manufacturers and regulators working in this space.
The amount of illegal diazepam tablets commandeered at the border of the UK doubled last year, according to a report.
In the wake of Brexit, the pharma industry will need to respond to a new regulatory landscape. Peter Morgan discusses how businesses have to prepare for the oncoming political changes, all whist retaining high pharmaceutical product quality.
Four companies are recalling batches of certain over-the-counter ranitidine medicines used to treat conditions such as stomach ulcers and heartburn.
The UK MHRA has issued an alert for the recall of unexpired Zantac products made by GSK due to the possible contamination of ranitidine in the medicines.
The government has announced new measures to prevent parallel exporting to ease the supply chain, in an effort to reduce medicine shortages.
Modernisation of microbiological test methods involves far more than just the science. As new systems and technologies become available it becomes increasingly important that potential users can identify not only the technical requirements, but also the business case. Here, Paul Newby, Alice Laures and Lisa Wysocki from GlaxoSmithKline discuss criteria…