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Results For "USFDA"

1353 News Found

Nia Therapeutics unveils first implantable brain interface for memory disorders
News | January 06, 2026

Nia Therapeutics unveils first implantable brain interface for memory disorders

The SNS records neural activity from 60 channels across four brain regions—far exceeding current commercial devices


FDA delays Corcept’s hypertension drug, seeks more evidence
Drug Approval | January 05, 2026

FDA delays Corcept’s hypertension drug, seeks more evidence

The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence


Elanco scores USDA nod for new canine allergy drug Befrena
News | January 04, 2026

Elanco scores USDA nod for new canine allergy drug Befrena

Elanco expects Befrena to launch in the US in the first half of 2026


Kokilaben Dhirubhai Ambani Hospital makes history with India’s first intercontinental remote robotic surgeries
Hospitals | December 31, 2025

Kokilaben Dhirubhai Ambani Hospital makes history with India’s first intercontinental remote robotic surgeries

The Toumai platform, currently the only robotic system with US FDA Study Approval for telesurgery, enabled real-time surgical control with no compromise to patient safety


FDA setback for Sanofi’s Tolebrutinib in progressive MS
Drug Approval | December 27, 2025

FDA setback for Sanofi’s Tolebrutinib in progressive MS

Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity


Hansa Biopharma submits FDA application for kidney transplant desensitization treatment
News | December 24, 2025

Hansa Biopharma submits FDA application for kidney transplant desensitization treatment

If approved, imlifidase has the potential to transform the kidney transplant landscape by enabling highly sensitized patients to also have access to a potentially life-changing kidney transplant


Abbott’s Volt PFA System gets FDA nod
News | December 24, 2025

Abbott’s Volt PFA System gets FDA nod

AFib is a progressive condition where timely intervention is critical to disease management and, ultimately, the patient's quality of life


Zydus Partners with Bioeq for US commercialisation rights for Nufymco
News | December 23, 2025

Zydus Partners with Bioeq for US commercialisation rights for Nufymco

NUFYMCO BLA has been approved by the USFDA


FDA grants breakthrough therapy designation to Enhertu for high-risk early breast cancer
Drug Approval | December 23, 2025

FDA grants breakthrough therapy designation to Enhertu for high-risk early breast cancer

This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care


Abbott wins FDA & CE nod for groundbreaking premature infant heart device
Medical Device | December 22, 2025

Abbott wins FDA & CE nod for groundbreaking premature infant heart device

The system is intended for some of the tiniest patients—premature infants weighing as little as two pounds