Diseases

FDA is requiring every GLP-1 receptor agonist label to carry a warning on NAION, a rare eye condition that can cause permanent vision loss. #SyenzaNews #drugsafety #GLP1

The FDA approved Sunharbo (asundexian), the first factor XIa inhibitor for stroke prevention, for adults after a recent ischemic stroke or high-risk TIA. #SyenzaNews #MarketAccess

The Enzutrix patent dispute goes to South Africa's Constitutional Court on 23 November 2026. UC and Astellas are pursuing damages over the generic prostate cancer drug, while Eurolab argues the patent was never validly obtained. #SyenzaNews #MarketAccess

Eli Lilly and Hims & Hers Health agreed to widen Zepbound and Foundayo telehealth access, with self-pay prices starting at $149 per month. #SyenzaNews #obesity #telehealth

BPOM is drafting a conditional approval route for the M72 TB vaccine and a joint review with the European Medicines Agency, ahead of Phase 3 results.

INFARMED recommends public funding for Refixia nonacog beta pegol in children under 12 with haemophilia B, based on two single-arm trials. #SyenzaNews #MarketAccess

SMA Europe has relayed Novartis's figures on tumour reports in patients previously treated with Zolgensma, including two cases of vector DNA integration.

The G-BA has found no proven added benefit for dupilumab in chronic spontaneous urticaria, compared with omalizumab plus second-generation H1 antihistamines.

"Truqap prostate cancer withdrawal: AstraZeneca pulled its EU bid for newly diagnosed use after EMA raised benefit-risk concerns." #SyenzaNews #MarketAccess

A Mayo Clinic cardiologist's TV-set question makes the case for a home blood pressure monitor, with a caution on device reliability and home data in the chart.

The Dutch health institute Zorginstituut Nederland has concluded that a second cochlear implant for adults with severe hearing loss in both ears belongs in the basic health package. #SyenzaNews #MarketAccess

FDA has finalized its potency assurance guidance for cell and gene therapy products. It covers lot-release testing, potency assays, acceptance criteria and how sponsors should build a strategy from the IND stage onward. #SyenzaNews #CellAndGeneTherapy #FDA