Zipalertinib achieved a 30.2% intracranial objective response rate and 72.1% intracranial disease control rate in 43 evaluable patients with EGFR-mutated lung cancer and active CNS metastases. The Phase 2 findings support further development, although the treatment remains investigational.
ZAP Surgical has secured $36 million in financing led by Catalio Capital Management, following shipment of its 50th ZAP-X system and treatment of nearly 10,000 patients worldwide. The investment will support manufacturing expansion and broader access to self-shielded brain radiosurgery.
GE HealthCare has introduced LOGIQ Focus, a general imaging ultrasound system combining cSound Architecture with automated scanning and workflow tools. In a third-party abdominal imaging study, the system completed scans 26% faster than a comparator, while 90% of participating physicians rated image quality highly.
Sound Pharmaceuticals has presented a new Phase 3 analysis showing statistically significant low-to-mid-frequency hearing improvements with SPI-1005 in Ménière's disease. The company believes the findings support development for sudden sensorineural hearing loss, although that separate indication has not been established in a dedicated pivotal trial.
PharmaEssentia will present six studies examining treatment gaps and real-world BESREMi use in essential thrombocythemia and polycythemia vera. The findings include 55% two-year treatment persistence in first-line PV users and new molecular response data from Asian patient populations.
Vivacta Bio and Grit Bio have secured FDA orphan drug designation for GT801 in autoimmune hemolytic anemia. Early findings from two patients showed complete responses following treatment with the investigational in vivo CAR-T therapy, which uses targeted lipid nanoparticles to generate CD19-directed immune cells inside the body.
Masimo has received FDA 510(k) clearance for atrial fibrillation detection on its Radius VSM monitor, reporting 97% sensitivity and 100% specificity in clinical validation. The feature joins an earlier-cleared respiratory depression algorithm, extending pulse oximetry into automated recognition of clinically important physiological patterns.
The EMA's CHMP has maintained its negative opinion on narsoplimab for transplant-associated thrombotic microangiopathy, citing unresolved clinical evidence concerns. Omeros disputes aspects of the re-examination and is shifting attention toward US commercialization and alternative patient access arrangements.
The FDA has approved satralizumab for adults with thyroid eye disease, introducing the first at-home subcutaneous treatment option. The decision follows two Phase 3 trials, one of which missed its primary endpoint, while the other demonstrated significant improvements in eye bulging and double vision.
Organon has reported a cumulative six-year Pearl Index of 0.93 and an estimated pregnancy rate of 3.9% for the hormone-free MIUDELLA intrauterine system. The findings support an FDA application to extend its approved use from three to six years, with a decision expected in the second quarter of 2027.