North America

FDA approved finerenone (Kerendia) for CKD associated with type 1 diabetes, the first new treatment for this population in 30 years. The label rests on a six-month UACR reduction, not hard kidney outcomes, so payers and HTA agencies will each have to decide how much credit the surrogate deserves. #SyenzaNews #MarketAccess #CKD #Type1Diabetes

WHO and St. Jude, with UNICEF and PAHO, have launched a 2026 to 2030 market-shaping strategy to improve access to childhood cancer medicines in low- and middle-income countries. #SyenzaNews #ChildhoodCancer #MarketAccess #Oncology

The FDA's landmark hearing on psychedelic medicines drew 80 speakers and 1,800 registrants, and the market access message was clear: approval is not access, and reimbursement is the binding constraint. #SyenzaNews #MarketAccess #Psychedelics #HealthPolicy

Enhertu's DESTINY-Lung04 trial cut the risk of progression versus chemo-immunotherapy in first-line HER2-mutant NSCLC, but an immature overall-survival trend and a 20.8% ILD rate complicate the path to a first-line label. #SyenzaNews #Oncology #NSCLC #MarketAccess

Every NCCN academic cancer center now reports a shortage of at least one anticancer medicine, led by ifosfamide (94%) and carboplatin (71%). Pharmacy directors say three years of policy have not moved the problem. #SyenzaNews #DrugShortages #Oncology #MarketAccess

Camizestrant (Etcamah) gains accelerated FDA approval for ESR1-mutated advanced breast cancer, with median progression-free survival of 16 months versus 9.2 months in SERENA-6. #SyenzaNews #BreastCancer #FDA #Oncology

US Medicare is paying for obesity GLP-1s for the first time, and more than 500,000 seniors signed up in the first two months. Our latest breaks down the $245 price, the $50 copay, and what it means for Lilly and Novo Nordisk. #SyenzaNews #MarketAccess #GLP1 #Medicare

Novartis and Bristol Myers Squibb have paused autoimmune CAR-T trials after inflammatory events and three deaths, putting the immune-reset thesis to its first real safety test. #SyenzaNews #CellTherapy #AutoimmuneDisease #MarketAccess

CTS's Global Horizon panel brought four US operators to Montréal to explain why the US healthcare market rewards commercial readiness over good technology, and what founders can do about it. #SyenzaNews #MarketAccess #HealthTech

The RECOVER-VITAL trial found nirmatrelvir-ritonavir offered no benefit for long COVID across cognitive, autonomic, or exercise symptoms. The study also shows why placebo controls matter: a large share of the placebo group improved on their own. #SyenzaNews #LongCOVID #ClinicalTrials #MarketAccess

FDA has authorized Stryker SportSuite Vision, the first surgical application built for Apple Vision Pro. The De Novo clearance is narrow: hip arthroscopy display, used alongside standard monitors. #SyenzaNews #DigitalHealth #MedTech #FDA #AppleVisionPro

Novartis' oral BTK inhibitor remibrutinib met its primary endpoint in the Phase III REMODEL-1 and REMODEL-2 trials, cutting annualized relapse rates versus teriflunomide in relapsing multiple sclerosis. #SyenzaNews #MultipleSclerosis #MarketAccess #Neurology