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Results For "nod"

304 News Found

Establishment Labs seeks FDA nod for Motiva breast reconstruction implants
News | January 01, 2026

Establishment Labs seeks FDA nod for Motiva breast reconstruction implants

Motiva, SmoothSilk, Round and Ergonomix implants represent the latest in plastic surgery innovation


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


GenSight Biologics gets early access nod for candidate gene therapy in Israel
Clinical Trials | December 31, 2025

GenSight Biologics gets early access nod for candidate gene therapy in Israel

Applications include detailed scientific rationale and supporting clinical evidence


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


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


Japan nod to Dupixent for children with severe asthma
Drug Approval | December 26, 2025

Japan nod to Dupixent for children with severe asthma

The decision is based on robust clinical evidence from the VOYAGE and EXCURSION studies


India's First: Curapod wearable gets Class II nod for drug-free musculoskeletal pain relief
Medical Device | December 24, 2025

India's First: Curapod wearable gets Class II nod for drug-free musculoskeletal pain relief

Provides pain relief for more than 30 conditions, including chronic back pain, arthritis, and sports injuries


FDA nod to Boehringer Ingelheim’s JASCAYD for progressive pulmonary fibrosis in adults
Drug Approval | December 24, 2025

FDA nod to Boehringer Ingelheim’s JASCAYD for progressive pulmonary fibrosis in adults

The study found that nerandomilast effectively slowed lung function decline in patients, with discontinuation rates similar to placebo


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


Bayer wins Japan nod for finerenone in broad heart failure population
Drug Approval | December 23, 2025

Bayer wins Japan nod for finerenone in broad heart failure population

Finerenone is the first therapy targeting the mineralocorticoid receptor pathway to demonstrate cardiovascular benefits in heart failure patients