Curated news and analysis on clinical trials, drug approvals, and medical research.
The FDA reversed its refusal to review Moderna’s mRNA flu vaccine application and accepted a revised filing with split age cohorts and a post-market study for adults over 65. The reversal came amid broader vaccine regulatory uncertainty and industry concern about unpredictable review timelines.
Support for non-animal testing is growing, but adoption remains slow. Great Britain recorded 2.64 million live animal uses in 2024, while the article cited regulatory barriers and high drug failure rates.
Eli Lilly reported positive phase 3b Together-PsO results for Taltz plus Zepbound in adults with plaque psoriasis and obesity or overweight. Separate meeting updates highlighted new oral plaque psoriasis therapies with biologic-like efficacy.
A study of 100 adults with diabetes found broad comfort with AI-based diabetic retinopathy screening, but most participants wanted physician oversight. The findings come as AI tools move further into community diabetes care.
Virginia State Police launched Operation DISS-Rupt on Interstate 81, a two-day enforcement effort targeting distracted and impaired driving, speeding and seat belt violations.
Two studies examined blood biomarkers for omalizumab response in chronic spontaneous urticaria. Basophil histamine content did not predict response, while higher baseline monocyte counts were linked to complete remission in a 52-patient retrospective analysis.
Phase 1 data in 17 adults with Friedreich's ataxia cardiomyopathy showed AAVrh.10hFXN (LX2006) was generally well tolerated and showed signs of biological activity. The gene therapy is being advanced into a larger trial.
Telix said Part 1 of the ProstACT Global Phase 3 study met its primary objectives for TLX591-Tx in mCRPC. The company reported acceptable safety, no new safety signals and progression plans for Part 2.
EMA released its 2026 network management report based on a survey of 352 IT professionals. It found only 31% have fully successful network operations strategies as AI and hybrid cloud complexity rise.
Soft tissue sarcoma pipeline activity includes 70+ companies and 75+ therapies. A phase II ADI-PEG 20 trial with gemcitabine and docetaxel was designed for sarcomas, while other 2026 studies span synovial sarcoma and unresectable advanced disease.
Rhythm reported Q1 2026 IMCIVREE revenue of $60.1 million and said more than 150 patient start forms were received after U.S. approval in acquired hypothalamic obesity. The company also cited European authorization and a Japanese application under review.
BrightGene Bio-Medical reported Phase III data for BGM0504 showing 19.3% mean weight reduction and improvements in blood pressure, lipids and uric acid. The data highlighted GIP as a key variable in broader metabolic management.
A review in Genes & Diseases says robust non-clinical safety assessment is critical for CRISPR-based gene therapies. It highlights genotoxic, delivery, and immunological risks and recommends risk-based development programs.
Trump secured agreements with 16 pharmaceutical companies tied to TrumpRx.gov, including most-favoured-nation pricing and direct-to-patient discounts. Several companies disclosed price cuts for obesity, diabetes, insulin and other medicines.
A large analysis of 131,821 health professionals found that two to three cups of caffeinated coffee a day were linked to a 19 percent lower dementia risk. One daily cup of caffeinated tea was linked to a 14 percent lower risk.
A 2026 review outlines the shift in solid organ transplantation from broad immunosuppression to Treg-based active tolerance. It covers polyclonal Tregs, CAR-Tregs and CRISPR-edited off-the-shelf products.
Recent studies in retinitis pigmentosa showed mixed results for gene and optogenetic therapies. UGX-201 and MCO-010 were associated with visual acuity improvements, while AAV8.hPDE6A showed no significant functional gains at 1 year.
Early clinical studies highlighted nonhormonal male contraception candidates YCT-529 and ADAM. YCT-529 showed favorable phase 1a safety, while ADAM reported mild transient effects and durability up to 24 months.
Hearings in Benjamin Netanyahu’s criminal trial were canceled this week after the death of a close family member of one presiding judge. The case remains in cross-examination in Case 4000, and Netanyahu is not expected back on the stand before next week.
A pooled analysis of five randomized trials found intranasal esketamine improved MADRS scores in adults with TRD in both sexes. Females showed greater improvement and higher odds of treatment-response toward trial end.
