Curated news and analysis on clinical trials, drug approvals, and medical research.
MannKind Corporation announced FDA approval of Afrezza inhaled mealtime insulin for pediatric patients with diabetes ages 6 and older. The approval makes Afrezza the first needle-free mealtime insulin alternative for children in over 100 years. Eligible patients can access Afrezza for $35 or less per month.
The NHS-Galleri trial of the Galleri multi-cancer early detection test did not meet its primary endpoint of reducing combined Stage III-IV cancers. Secondary results showed a 26% reduction in Stage IV diagnoses by the third screening round for 12 deadly cancers. The test increased cancer detection rates four-fold compared to standard screening alone.
BioNTech presented phase 2 data for HER2-directed ADC Trastuzumab Pamirtecan showing 47.9% response rate in endometrial cancer, with FDA submission planned for 2026. BioLineRx dosed first patient in phase 1/2a GLIX1 trial for glioblastoma and reported new preclinical data. Both companies presented at ASCO 2026.
Recent studies and expert discussions highlight using ctDNA testing to guide surgery decisions for older ER-positive breast cancer patients and integrating FAST-Forward and PRIME II trial data to personalize radiation therapy and sequence with ADCs like T-DXd.
Two new studies reveal long COVID's lasting biological and mental health effects. A mouse study found coronavirus triggers prolonged lung and brain damage unlike influenza, while a population study linked long COVID to significantly higher depression and anxiety risks up to three years post-infection.
The phase III frontMIND trial showed that adding tafasitamab and lenalidomide to R-CHOP chemotherapy reduced the risk of progression by 25% in patients with high-risk B-cell lymphomas. The 3-year progression-free survival was 67.3% with the combination versus 60.7% with R-CHOP alone. A dual-targeted CD19/CD20 immunotherapy regimen has also been approved in Australia for relapsed follicular lymphoma.
Experts warn that Most Favored Nation drug pricing policies, including Florida's HB 697, could increase patient costs, reduce access to new treatments, and undermine pharmaceutical innovation while failing to guarantee savings reach consumers.
The phase 3 ROSELLA trial showed relacorilant plus nab-paclitaxel significantly improved overall survival in platinum-resistant ovarian cancer by 4.1 months versus nab-paclitaxel alone. The benefit was consistent across all subgroups regardless of prior taxane exposure, leading to FDA approval in March 2026. The combination also met its progression-free survival endpoint and demonstrated a favorable safety profile.
Tempus has launched "Preview," an AI-powered tool that provides early cancer insights within one day of sample receipt to inform treatment planning. The tool focuses on high-impact biomarkers including MSI-H, EGFR mutations, and FGFR fusions across several cancer types. The launch aligns with expert emphasis on the critical role of early biomarker testing in personalizing therapy for EGFR-mutated NSCLC.
GRAIL's NHS-Galleri trial missed its primary endpoint of reducing combined Stage III and IV cancer diagnoses. However, the trial showed a 26% reduction in Stage IV diagnoses by the third screening round. Results were presented at ASCO 2026, and GRAIL stock fell following the announcement.
Two experimental ALS therapies showed promise in recent clinical developments. Interim Phase 1/2 data suggest the antisense oligonucleotide QRL-201 restores a critical nerve protein and may slow disease decline, with a Phase 3 trial planned for 2027. Meanwhile, the oral therapy neflamapimod has been selected for testing in the UK's EXPERTS-ALS platform study, with first results expected this spring.
UCLA-led research finds telemedicine has not significantly increased healthcare visits or costs across all payer types from 2019-2023, published in JAMA Network Open. A separate study of Medicare patients reveals nearly half of telehealth visits are for non-mental health conditions, particularly chronic diseases like diabetes and high blood pressure. Both findings address questions about telehealth's role and impact since the COVID-19 pandemic.
Researchers developed BIDSleep, an AI framework that uses Apple Watch data to accurately classify sleep stages, achieving 71% accuracy in a clinical study. Separately, startup SOND launched AI-powered earbuds that track physiological signals to enhance sleep. Both advances demonstrate the expanding role of AI and wearables in sleep science.
FDA approves MannKind's Afrezza inhaled insulin for children aged 6+ with type 1 and type 2 diabetes. Separately, an updated label provides new starting dose guidance for adults switching from injections or insulin pumps.
BMS's mezigdomide doubled progression-free survival in relapsed/refractory multiple myeloma at ASCO, while the FDA reviews iberdomide with a decision due by August 17. C4 Therapeutics has dosed the first patient in its Phase 2 MOMENTUM trial of cemsidomide.
GSK's Phase III B-Well trials show bepirovirsen achieved 19% functional cure in chronic hepatitis B, rising to 26% in patients with lower viral activity, versus 0% for placebo. Regulatory decisions are expected in Q3 2026.
Immunic presented new Phase 2 CALLIPER data at CMSC 2026 showing vidofludimus calcium's favorable effects in progressive MS, including a novel unified disability endpoint. The company also secured $400M in private placement to fund Phase 3 ENSURE studies and commercial preparations.
NICE updates type 2 diabetes guidance in England, recommending earlier use of SGLT-2 inhibitors and GLP-1 receptor agonists. Separately, a study finds SGLT2 inhibitors improve survival in Takotsubo syndrome patients.
Apogee Therapeutics will present Phase 2 APEX Part B data for zumilokibart on May 27, 2026. Affinity Asset Advisors increased its stake to 1.23 million shares valued at $93.21 million. The stock rose 86.9% over the past year.
Three trials show ultra-low-dose checkpoint inhibitors retain efficacy with reduced toxicity and dramatically lower costs. DELII and Patil et al. trials tested low-dose nivolumab in solid tumors and HNSCC; NIVIPIT tested intratumoral low-dose ipilimumab in melanoma.
