The government has announced it is slashing the red tape that holds back groundbreaking innovations from coming to market.
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The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 15 July 2025, approved sebetralstat (Ekterly) for the treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older.
Guidance: CLOSED AI Airlock Phase 2 application
The call for applications for phase 2 of the AI Airlock is now closed.
Mesalazine and idiopathic intracranial hypertension
Idiopathic intracranial hypertension (IIH) has been very rarely reported in patients treated with mesalazine. Following a recent review, warnings for IIH are being added to the product information for all mesalazine products.
Field Safety Notices: 25 to 29 August 2025
List of Field Safety Notices from 25 to 29 August 2025.
MHRA confirms taking paracetamol during pregnancy remains safe and there is no evidence it causes autism in children
Paracetamol should be taken as directed in the patient information leaflet
MHRA statement on new review of paracetamol safety during pregnancy
Paracetamol should be taken as directed in the patient information leaflet.