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Results For "approval"

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StimLabs secures FDA nod for groundbreaking human umbilical cord-derived device
Medical Device | January 01, 2026

StimLabs secures FDA nod for groundbreaking human umbilical cord-derived device

Theracor is derived from human umbilical cord extracellular matrix (ECM) and is designed to cover, protect, and maintain a moist wound environment


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


Diamyd Medical accelerates Phase 3 Type 1 diabetes trial following FDA guidance
Clinical Trials | December 31, 2025

Diamyd Medical accelerates Phase 3 Type 1 diabetes trial following FDA guidance

The interim efficacy readout, involving around 170 participants with 15-month data, remains on track for the end of March 2026


Cupid to set up FMCG manufacturing facility in Saudi Arabia
News | December 30, 2025

Cupid to set up FMCG manufacturing facility in Saudi Arabia

The plant is expected to enhance regional supply capabilities


INOVIO’s DNA therapy for rare throat disease gets FDA review
Biotech | December 30, 2025

INOVIO’s DNA therapy for rare throat disease gets FDA review

INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway


ENHERTU gains first-ever nod in China for metastatic breast cancer
Drug Approval | December 29, 2025

ENHERTU gains first-ever nod in China for metastatic breast cancer

The approval follows results from the DESTINY-Breast06 phase 3 trial, which showed ENHERTU significantly extended progression-free survival compared to chemotherapy


FDA okays AQVESME as first treatment for anemia in alpha- & beta-thalassemia
News | December 27, 2025

FDA okays AQVESME as first treatment for anemia in alpha- & beta-thalassemia

The approval makes AQVESME the only FDA-approved therapy for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia


InnoCare Pharma gets green light for Phase II trial of oral lupus drug
Clinical Trials | December 27, 2025

InnoCare Pharma gets green light for Phase II trial of oral lupus drug

CLE, a common form of lupus erythematosus, primarily causes diverse skin lesions


EU nod to Wayrilz as breakthrough treatment for hard-to-treat ITP
Drug Approval | December 27, 2025

EU nod to Wayrilz as breakthrough treatment for hard-to-treat ITP

Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation