Curated news and analysis on clinical trials, drug approvals, and medical research.
European guidelines now recommend lutetium-177 PSMA-617 for advanced prostate cancer, while a machine-learning model predicts treatment radiation dose. A study finds DOACs safe with modern prostate cancer drugs.
The FDA has approved Shionogi's XOCOVA (ensitrelvir) as the first oral antiviral for post-exposure prophylaxis of COVID-19. Approval was based on the Phase 3 SCORPIO-PEP trial, which showed a 67% reduction in risk of symptomatic disease after exposure.
The FDA has accepted for review a New Drug Application for tirabrutinib, a Bruton tyrosine kinase inhibitor, for relapsed or refractory primary central nervous system lymphoma. The application is based on phase 2 PROSPECT trial data showing an overall response rate of 67% and complete response rate of 44%. The target action date is December 18, 2026.
CARsgen Therapeutics has signed a RMB370 million agreement to build a CAR T-cell manufacturing base in Shanghai, supporting commercialization of its marketed and late-stage products. Meanwhile, investment firm HarbourVest disclosed a $21 million position in CAR-T developer Generate Biomedicines, which holds $516.6 million in cash after its IPO.
An experimental pill called daraxonrasib nearly doubled survival for patients with advanced pancreatic cancer in a clinical trial, marking a significant advance for a deadly disease. The drug targets a mutated protein previously considered "undruggable" and reduced the risk of death by 60% compared to chemotherapy.
Moleculin Biotech's Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine in relapsed or refractory acute myeloid leukemia reported a preliminary complete remission rate of approximately 30% and composite remission rate exceeding 40% in the first 45 subjects. The blinded data show a substantial improvement over historical rates with cytarabine alone. The trial is expected to reach its first unblinding milestone in mid-2026.
The FDA has approved Pfizer's BRAFTOVI for BRAF V600E metastatic colorectal cancer and VEPPANU for ESR1 mutated breast cancer. The oncolytic virus cancer therapy pipeline expands with over 120 companies developing 125+ drugs. Positive late-stage data for other Pfizer oncology programs was also reported.
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.
