Also known as: New England Journal of Medicine
Baxfendy was approved in the US for hypertension in adults not adequately controlled on other antihypertensive medicines. The approval was based on Phase III BaxHTN results showing significant systolic blood pressure reductions.
Three advances in TB diagnostics: a portable $300 device delivering results in 30 minutes, a Quick DNA kit detecting drug resistance in 5 minutes, and an ultrasensitive test finding TB DNA in 12-16% of hospitalized US patients.
New therapies including CAR-T, bispecific antibodies and dual-antibody immunotherapy are reshaping multiple myeloma care. Advances in genomic testing may also improve risk assessment and treatment decisions.
Vermont insurers and employers are scaling back GLP-1 coverage as costs rise, leaving some patients without access. The drugs remain in high demand as studies point to benefits beyond weight loss.
FDA has accepted the NDA for vepdegestrant (ARV-471), an oral PROTAC ER degrader from Arvinas and Pfizer, for ESR1-mutated ER+/HER2- advanced breast cancer. A PDUFA date of June 5, 2026 has been set. The submission is based on positive Phase 3 VERITAC-2 data.
A study in stage 3 dMMR colon cancer found that atezolizumab plus chemotherapy after surgery cut recurrence and death risk by 50%. The trial enrolled 712 patients and the regimen is now included in treatment guidelines.
The FDA plans to make one study the default for some new drug approvals instead of two robust clinical trials. The shift could have its biggest effect on drugs for common ailments.
The European Commission approved Enflonsia for prevention of RSV lower respiratory tract disease in infants during their first RSV season. Merck also reported new Phase 3 SMART data showing generally consistent second-season safety in high-risk children under 2 years old.
A paper in the New England Journal of Medicine argues the Supreme Court should reject FDA-required drug labels as standalone evidence of patent infringement in Hikma Pharmaceuticals USA v. Amarin Pharma. The paper says lower-court guidance raises liability risk for generic-drug manufacturers complying with FDA rules and could hamper competition.
The FDA will drop its longtime requirement for two rigorous studies to approve new drugs, moving to a default position of requiring only one study. Commissioner Marty Makary says the change reflects modern scientific advances and aims to accelerate drug availability without compromising safety. The shift follows decades of increasing flexibility for rare and fatal diseases, with about 60% of first-of-a-kind drugs already approved based on single studies in recent years.
