North America

FDA approval of the Autus Size-Adjustable Valve gives children with congenital pulmonary valve disease a pulmonary valve that can be widened as they grow, from 13 millimeters to 22 millimeters. The evidence base is 62 patients and six months of follow-up. #SyenzaNews #medicaldevices #pediatrics #MarketAccess

A once-weekly selective amylin agonist added to tirzepatide cut 23.3% of body weight in 367 adults with obesity and type 2 diabetes, against 14.8% for tirzepatide 15 mg alone. Lilly plans Phase 3 of a co-formulated EloraTZP by the end of 2026. Discontinuation rates that reach 27% in the highest-dose arm will be the detail payers study first. #SyenzaNews #obesity #type2diabetes #MarketAccess

OMB has opened a request for information on domestic and near shore manufacturing of the ASPR 86 essential medicines. Manufacturers have until 26 October 2026 to declare idle capacity, set out new plant plans, and name the unit price they need to stay viable. #SyenzaNews #MarketAccess #pharmaceuticalmanufacturing

The Bureau of Industry and Security has named nine product classes and 19 jurisdictions that can ship specialty medicines into the United States at a zero tariff, while the 100 percent Section 232 duty reaches most patented pharmaceuticals on 29 September 2026. Companies arguing an urgent U.S. health need now have a defined route to apply. #SyenzaNews #MarketAccess #PharmaceuticalTariffs

A National Press Foundation briefing on drug prices and workforce shortages: separate list price from net price, ask which goal a policy serves, and check whether more clinicians really mean more appointments. #SyenzaNews #HealthEconomics #MarketAccess

The FDA has granted full approval to Inluriyo plus Verzenio for ESR1-mutated metastatic breast cancer. In the Phase 3 EMBER-3 trial, the all-oral combination doubled median progression-free survival versus Inluriyo alone, at 11.1 months versus 5.5 months. #SyenzaNews #Oncology #MarketAccess

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