Regulation

Singapore-based Cuprina now holds FDA commercial rights to both maggot species used in debridement therapy, a position the company says no rival holds.

Pharvaris reported Phase 3 RAPIDe-3 data showing deucrictibant halted HAE attack progression in a median 17 minutes versus nearly four hours for placebo.

Pooled PATHFNDR open-label extension data show paltusotine maintained IGF-1 control and stable tumour volumes for up to 96 weeks in acromegaly patients.

The California biotech is crowdfunding to advance XGal-3, an FDA Breakthrough Device-designated apheresis system targeting Galectin-3 in sepsis.

Phase 3 SENTRY data showed selinexor plus ruxolitinib achieved SVR35 in 49.8% of myelofibrosis patients versus 28% on ruxolitinib alone at week 24.

Proteomic analysis of over 1,000 trial participants found lorundrostat reduced six of eleven heart failure risk biomarkers, including NT-proBNP.

New analyses from Agios's EHA 2026 plenary presentation show mitapivat reduced transfusion burden by 41% and improved pain and fatigue in sickle cell responders.

Phase 2 data presented at EHA 2026 show epcoritamab monotherapy and a combination regimen achieved strong complete response rates in first-line elderly DLBCL patients.

Insight Molecular Diagnostics says its combination model score outperforms single-metric dd-cfDNA in a peer-reviewed study of 414 kidney transplant patients.

Phase 3 results for lonvo-z, published simultaneously in the NEJM, showed 62% of patients attack-free over six months with a single dose.

Phase 3 MonumenTAL-3 data show talquetamab combinations beat standard care on PFS and OS in earlier-line relapsed myeloma.

Six-month interim data from 17 patients showed BMI reductions, fat mass loss and improved hyperphagia scores, reinforcing the case for Phase 3.

FDA has authorised Alpha Tau to enrol the final seven patients in its REGAIN recurrent glioblastoma trial following encouraging interim data from the first three

Belite Bio has filed its full NDA for tinlarebant, a once-daily oral therapy that would be the first approved treatment for STGD1.

Bezuclastinib hit a 65% objective response rate in advanced systemic mastocytosis; Cogent plans to file its NDA in June 2026.

DISC-0974 hit major response rates of 50–64% across transfusion subgroups in myelofibrosis, with End of Phase 2 FDA talks targeted for late 2026.

Post-hoc MATTERHORN data presented at EHA 2026 show roxadustat achieved transfusion independence in both RS-positive and RS-negative lower-risk MDS patients.

Updated Phase 1/2 data in 108 LBCL patients show no Grade 3+ CRS and a 97% manufacturing success rate, supporting outpatient use.

RemIND trial data presented at EAACI 2026 show remibrutinib doubled complete response rates versus placebo in symptomatic dermographism, cold urticaria and cholinergic

The accelerated approval covers children aged eight to 17 recently diagnosed with stage 3 T1D, making Tzield the first disease-modifying therapy in this setting.