30 September 2025
From the newsfeeds of the Medicines and Healthcare products Regulation Agency, Arex Advisor has rounded up a selection of highlights from September 2025.
MHRA approves first new UTI antibiotic in nearly 30 years
28 August 2025
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorised gepotidacin, the first new class of antibiotic for urinary tract infections (UTIs) in almost three decades. UTIs are the most common bacterial infection in women, and with rising antimicrobial resistance, new treatment options are seen as essential to prevent complications such as sepsis or kidney damage. The MHRA will continue to monitor the medicine’s safety closely. Read more
Updated forms available for manufacturer’s licence variations
9 September 2025
The MHRA has published updated forms for submitting variations to a manufacturer’s licence. The revised documents are now available for use. Read more
MHRA approves vorasidenib for certain brain tumours
16 September 2025
The MHRA has authorised vorasidenib (Voranigo) for patients aged 12 and over with grade 2 astrocytoma or oligodendroglioma carrying an IDH1 or IDH2 mutation. The treatment is intended for use in patients who do not require immediate chemotherapy or radiotherapy after surgery. Read more
MHRA blog series on future strategy
16 September 2025
As it develops a new five-year strategy, the MHRA has begun publishing a series of blogs exploring key challenges and opportunities. In the first post, Chief Executive Lawrence Tallon reflects on the evolving healthcare landscape, the agency’s regulatory role, and the priorities guiding its future direction. Read more
MHRA confirms paracetamol safe to use in pregnancy
22 September 2025
The MHRA has reaffirmed that paracetamol remains safe for use during pregnancy and stressed that no evidence links it to autism in children. The agency advises patients to follow the instructions provided in the patient information leaflet. Read more
UK opens Moderna centre and launches £50m life sciences fund
25 September 2025
A new Moderna Innovation and Technology Centre has opened in Oxfordshire, boosting the UK’s vaccine manufacturing capacity. At the same time, the government has announced a £50 million fund to further strengthen the life sciences sector. Read more
MHRA and partners issue updated notice on weight-loss drug ads
26 September 2025
The MHRA and partner organisations have published an updated joint Enforcement Notice on advertising rules for prescription weight-loss medicines. The guidance clarifies the types of claims and imagery in adverts that are likely to breach regulations. Read more
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