UK Life Sciences Regulatory & Approval News
Regulatory decisions can determine when a study begins, a product reaches a market or a facility is authorised to perform regulated work. This category follows formal approvals, designations, clearances and accreditations affecting UK life sciences organisations.
AstraZeneca Wins FDA Accelerated Approval for Ultomiris in IgA Nephropathy
AstraZeneca has received FDA accelerated approval for Ultomiris in adults with IgA nephropathy, based on an interim analysis showing a 43.4% reduction in proteinuria versus placebo at 34 weeks. The trial continues to 106 weeks to assess whether the drug slows loss of kidney function, which would support full approval.
GSK Wins FDA Approval for First-in-Class Hepatitis B Drug Hibsago
GSK has received FDA approval for Hibsago (bepirovirsen), a first-in-class antisense oligonucleotide given as a six-month course, for adults with chronic hepatitis B. Approval was based on the Phase 3 B-Well 1 and B-Well 2 trials, in which 19% of patients achieved functional cure versus none on placebo.
Abingdon Health's Doncaster Laboratory Gains ISO/IEC 17025 Accreditation
Abingdon Health's subsidiary Abingdon Analytical has received ISO/IEC 17025:2017 accreditation from UKAS for its Doncaster performance evaluation laboratory, its first. The lab provides testing that diagnostics developers include in UKCA, EU IVDR and FDA regulatory submissions.
Tropic's Non-Browning Banana Confirmed as Precision Bred by Defra
Tropic has received Defra confirmation that its gene-edited non-browning banana is precision bred under the Genetic Technology (Precision Breeding) Act 2023. The banana, edited with CRISPR-Cas9 to reduce polyphenol oxidase, still requires Food Standards Agency authorisation before it can be sold in England, and Tropic is targeting commercial introduction from 2027.
John Innes Centre secures first UK marketing notice for precision-bred tomato
John Innes Centre has secured England's first marketing notice for a precision-bred tomato, approving its biofortified "Sunshine" variety under Defra's Precision Bred Organism framework. Developed by Professor Cathie Martin's team using CRISPR-Cas9 to knock out a gene involved in vitamin D3 breakdown, the tomato accumulates high levels of pro-vitamin D3 in its fruit and leaves; it still needs Food Standards Agency approval before it can reach shops.