Clinical Practice

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.

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

A Congressional Research Service sidebar maps the state lawsuits over AI in health care, from insurer claim denials to wellness apps and chatbots.

"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 Ministry of Food and Drug Safety hosts ICMRA, the international coalition of medicines regulators, in Seoul from 3 to 6 November 2026, with AI rules and alternatives to animal testing on the agenda. #SyenzaNews #MarketAccess #drugregulation

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

EMA's safety committee has opened a Deanxit safety review at Belgium's request, after reports of movement disorders and memory problems with the flupentixol/melitracen combination. The Belgian agency also questioned the benefit of combining the two substances. #SyenzaNews #Pharmacovigilance #EMA #MentalHealth