Life science news 22 June 2026: the FDA clears the first disease-modifying therapy for newly diagnosed childhood type 1 diabetes, the MHRA approves the UK’s first cancer treatment delivered by on-body injector, and GSK wins approval for the first oral carbapenem antibiotic in a busy week for pharma, biotech and healthcare.
The US Food and Drug Administration approved a new indication for Tzield (teplizumab) on 12 June, granting accelerated approval to delay the decline in insulin production in children aged 8 to 17 who have recently been diagnosed with Stage 3 type 1 diabetes. Announced on 15 June, the decision is the first disease-modifying therapy cleared for new-onset Stage 3 disease in this age group, having previously been approved to delay the onset of Stage 3 diabetes in people with Stage 2 disease. The approval rested on a controlled trial showing a statistically significant effect on C-peptide, a surrogate marker reasonably likely to predict clinical benefit, with a confirmatory study ongoing. Tzield, marketed by Sanofi, carries a boxed warning relating to viral reactivation.
The MHRA approved a subcutaneous formulation of Sanofi’s Sarclisa (isatuximab) on 18 June for the treatment of multiple myeloma, across the indications already cleared for the intravenous version. The decision makes Sarclisa the first anti-cancer treatment in the UK that can be given through an on-body injector, the wearable CirCLIQ device, or as a manual injection under the skin, allowing administration in outpatient clinics or at home and reducing time spent in hospital. The UK is the first market to approve the on-body-injector version outside the EU, where the European Commission cleared it on 8 June, and the MHRA approval was supported by the Phase 3 IRAKLIA study that found the subcutaneous formulation non-inferior to the intravenous one.
GSK and Spero Therapeutics secured FDA approval for Utebzi (tebipenem pivoxil) on 17 June, the first and only oral carbapenem antibiotic cleared for adults with complicated urinary tract infections, including pyelonephritis, who have limited or no alternative oral options. The approval was supported by the Phase 3 PIVOT-PO trial in 1,690 hospitalised patients, in which the oral therapy proved non-inferior to intravenous imipenem-cilastatin. The British drugmaker, which developed the antibiotic under a licensing agreement with Spero, said the treatment could reduce reliance on hospital-based intravenous care as antimicrobial resistance rises, and expects it to be available by the end of 2026.
Merck won an expanded FDA indication for Capvaxive, its 21-valent pneumococcal conjugate vaccine, on 18 June, broadening use to children and adolescents aged 2 to 17 who have completed a primary pneumococcal vaccination series and have one or more chronic conditions that raise their risk of pneumococcal disease. The expansion makes Capvaxive the first pneumococcal conjugate vaccine studied and indicated in the US as a supplemental dose for this higher-risk paediatric group, and was supported by the Phase 3 STRIDE-13 trial in 874 children and adolescents. The vaccine was first approved for adults in 2024.
In further life science news 22 June 2026, the week brought a run of US regulatory firsts, a major life sciences software acquisition, fresh biotech financing and an international cancer approval, underlining the steady pace of activity across pharma and biotech as the sector heads towards the midpoint of the year.
The FDA approved the first generic of Xofluza (baloxavir marboxil) on 17 June, the first single-dose treatment for acute uncomplicated influenza, and for post-exposure prevention of the infection, in patients aged 5 and over. Cleared in time for the 2026 to 2027 flu season, the approval went to Norwich Pharmaceuticals and is intended to improve affordability and ease of use by adding a lower-cost, single-dose oral alternative to the branded product.
Simulations Plus agreed to be acquired by healthcare investment firm Altaris on 16 June in an all-cash deal worth approximately $375 million, or $18.50 per share, a 26% premium to the company’s 60-day volume-weighted average price. Simulations Plus provides model-informed and AI-accelerated drug-development software, and Altaris said it intends to combine the business with its portfolio company Chemical Computing Group, a molecular-design software provider. The transaction reflects continued consolidation across AI-enabled life sciences tools.
cAMPfield Therapeutics launched with a $180 million Series A financing on 18 June to advance prifemilast, a once-daily oral PDE4B-selective inhibitor, into global Phase 2 trials in moderate-to-severe ulcerative colitis and Crohn’s disease. The San Diego company, founded by Mountainfield Venture Partners and led by veterans of several established immunology drugs, in-licensed the candidate from China’s Newsoara Biopharma for territories outside Greater China. The round was led by Frazier Life Sciences and drew a syndicate including Forbion, Abingworth, Venrock, Novo Holdings and RA Capital.
Incyte secured Japanese approval for Minjuvi (tafasitamab) on 19 June, after Japan’s Ministry of Health, Labour and Welfare cleared the CD19-targeting antibody in combination with lenalidomide for adults with relapsed or refractory diffuse large B-cell lymphoma. DLBCL is the most common subtype of non-Hodgkin lymphoma, and outcomes remain poor for patients whose disease returns or fails to respond, particularly those ineligible for a stem-cell transplant. Incyte licenses worldwide rights to tafasitamab from Xencor.
That’s your life science news digest for 22 June 2026, back next Monday with the latest from pharma, biotech and healthcare at www.lifesciencedaily.news. Catch up on the 15 June news roundup.
