Following an initial rebuff in February 2026, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is recommending approval of Acadia Pharmaceuticals Inc.’s Daybu (trofinetide) for treating neurobehavioral symptoms of Rett syndrome, after it took another look at the file.

Johnson & Johnson this week launched its dual-energy Thermocool Smarttouch SF platform in Europe bringing another option to physicians looking to enhance their electrophysiology procedures. The system combines radiofrequency (RF) and pulsed field ablation in one device to treat atrial fibrillation, entering what is becoming an increasingly crowded market for cardiac ablation technology.

As expected, and following impressive phase III data released last September, Ionis Pharmaceuticals Inc. won U.S. FDA approval of Tryngolza (olezarsen) for adults with severe hypertriglyceridemia, unlocking a larger indication and one that held both priority review and breakthrough therapy designations.

Croívalve Ltd. secured a further $20 million in series B financing for its Duo Adapt system, a transcatheter device that treats tricuspid regurgitation. The company also received $7 million from the European Innovation Council and the Disruptive Technologies Innovation Fund in grant financing. Croívalve will use the funds to expand its clinical study, which is evaluating the safety and performance of the Duo Adapt system in patients with severe or greater symptomatic tricuspid regurgitation.

Europe must focus on prevention and innovation to ensure its health care systems are sustainable in the long term, said Olivér Várhelyi, European commissioner for health and animal welfare. With an aging population, rising chronic diseases, a stretched workforce and geopolitical tensions, the universal health coverage that Europeans enjoy is under threat, he told delegates at the HLTH Europe conference in Amsterdam last week.

Chinese peptide therapeutics developer Shaanxi Micot Pharmaceutical Technology Co. Ltd. is seeking up to HK$1.22 billion (US$155 million) in a Hong Kong IPO to advance its lead phase III chronic kidney disease candidate, MT-1013, and next-generation obesity therapies.

Demonstrating better tolerability and safety in comparison with standard of care, Edgewise Therapeutics Inc.’s EDG-7500 is moving toward a phase III trial for both obstructive and nonobstructive hypertrophic cardiomyopathy (HCM), the most common form of genetic heart disease. Boulder, Colo.-based Edgewise reported top-line phase II results from part D of the Cirrus-HCM trial, showing meaningful responses in terms of hemodynamics, biomarkers and patient-reported measures.

Fresh off a deal with Travere Therapeutics Inc. for civorebrutinib worth more than $1.14 billion, Everest Medicines Ltd. went on a shopping spree, striking three deals in six days to expand its pipeline and geographic reach across Asia Pacific.

The U.S. Supreme Court handed Hikma Pharmaceuticals and the entire generic industry a big victory June 4 with its 9-0 opinion ensuring the future of skinny labels and correcting the Federal Circuit’s flawed understanding of infringed inducement.