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GE HealthCare receives FDA clearance for AI-powered Pristina Recon DL mammography system
26 November 2025 - Healthcare solutions provider GE HealthCare (Nasdaq: GEHC) announced on Wednesday that it has received U.S. FDA Premarket Authorization for Pristina Recon DL, a 3D mammography reconstruction technology powered by deep learning. The...
BeOne Medicines' sonrotoclax granted FDA Priority Review for relapsed or refractory mantle cell lymphoma
26 November 2025 - Oncology company BeOne Medicines Ltd (Nasdaq: ONC) (HKEX: 06160) (SSE: 688235) announced on Wednesday that the U.S. Food and Drug Administration has granted Priority Review to the company's New Drug Application for sonrotoclax...
Remington Medical's VascuChek 2.0 Cordless Bluetooth-Enabled Doppler Secures FDA Clearance
26 November 2025 - Remington Medical has confirmed that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its updated VascuChek® Doppler, marking the official commercial launch of the second-generation device. Designed ...
Valneva reports positive final Phase 2 results for Lyme disease vaccine VLA15
26 November 2025 - Vaccine company Valneva SE (Nasdaq:VALN) (Euronext Paris:VLA) on Wednesday reported positive final Phase 2 immunogenicity and safety results for its Lyme disease vaccine candidate, VLA15.The study showed strong anamnestic immune re...
AstraZeneca wins US approval for Imfinzi as first perioperative immunotherapy in early gastric and GEJ cancer
26 November 2025 - Biopharmaceutical company AstraZeneca PLC (LSE: AZN) (STO: AZN) (Nasdaq: AZN) announced on Wednesday that it has secured US approval for Imfinzi as the first perioperative immunotherapy for adults with resectable early-stage and lo...