MHRA

In a significant breakthrough for lung cancer treatment, the National Institute for Health and Care Excellence (NICE) has endorsed alectinib, known commercially as Alecensa,...

The National Institute for Health and Care Excellence (NICE) has stirred discussion in the medical community by questioning the value of donanemab, a new...

A recent groundbreaking study has highlighted significant advancements in treating diabetic macular edema (DME) for African American, Black, Hispanic, and Latino populations. Conducted by...

The UK is on the brink of a significant breakthrough in public health, as the first Phase 3 clinical trial for an mRNA norovirus...

Artificial intelligence (AI) continues to redefine traditional business landscapes, integrating itself into various sectors with remarkable speed. Its applications stretch beyond tech companies, offering...

Key TakeawaysElafibranor (Iqirvo) is now approved by the MHRA to treat adults with primary biliary cholangitis (PBC), a rare chronic liver disease. The...

Key TakeawaysThe MHRA is asking patients to report any safety issues with continuous glucose monitors (CGMs) or insulin pumps through the Yellow Card...

Key TakeawaysThe MHRA has approved leniolisib phosphate (Joenja) for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS), a rare immune disorder. This...

Key TakeawaysThe Windsor Framework, fully effective from January 2025, introduces a two-category system for UK medicines, increasing regulatory complexity between the UK and...

In the fast-paced world of medical device regulation, clear definitions of intended purpose and indications for use are paramount. These elements not only influence...

Key TakeawaysModerna’s updated Spikevax® JN.1 COVID-19 vaccine has received MHRA approval in the UK, targeting the JN.1 Omicron subvariant to protect high-risk individuals...

Key Takeaways:The Carevix device by Aspivix has received approval from the Medicines & Healthcare products Regulatory Agency (MHRA) in the UK, marking a...

Key TakeawaysThe TİTCK has released an updated "Guideline on the Procurement of Medicines from Abroad," streamlining the process for importing essential pharmaceuticals that...

Alzheimer’s disease (AD) has taken another significant step forward in treatment, with the authorization of Leqembi® (lecanemab) in Great Britain for the treatment of...

Predictive Health Intelligence's groundbreaking product, hepatoSIGHT™, has received Class I medical device clearance from the Medicines and Healthcare products Regulatory Agency (MHRA), marking a...