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Results For "approval"

2618 News Found

FDA approves Lenire device by Neuromod for tinnitus treatment option for US veterans
Medical Device | June 19, 2024

FDA approves Lenire device by Neuromod for tinnitus treatment option for US veterans

Lenire is the first and only bimodal neuromodulation device to be awarded a Federal Supply Schedule (FSS) Contract from the US Government


Imfinzi approved in the US for endometrial cancer
Drug Approval | June 17, 2024

Imfinzi approved in the US for endometrial cancer

Approval based on DUO-E trial results, which showed Imfinzi reduced the risk of disease progression or death by 58% vs. chemotherapy


USFDA approves next-gen TKI Augtyro for treatment of solid tumors
Drug Approval | June 17, 2024

USFDA approves next-gen TKI Augtyro for treatment of solid tumors

Augtyro is the only FDA-approved treatment option for NTRK-positive tumors studied in both TKI-naïve and TKI-pretreated patients across solid tumors


Farxiga approved in the US for the treatment of paediatric type-2 diabetes
Drug Approval | June 14, 2024

Farxiga approved in the US for the treatment of paediatric type-2 diabetes

Approval based on results from T2NOW, one of the largest paediatric type-2 diabetes Phase III trials to date


USFDA approves expanded age indication for GSK’s RSV vaccine ‘Arexvy’
Clinical Trials | June 14, 2024

USFDA approves expanded age indication for GSK’s RSV vaccine ‘Arexvy’

Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes


Suven to acquire a majority stake in CDMO player ‘Sapala Organics’
News | June 14, 2024

Suven to acquire a majority stake in CDMO player ‘Sapala Organics’

Sapala has a strong customer base including innovator Pharma, CDMOs & diagnostic companies


Torrent Pharmaceuticals gets Form 483 with 5 observations for Indrad facility
Drug Approval | June 13, 2024

Torrent Pharmaceuticals gets Form 483 with 5 observations for Indrad facility

There was no observation related to data integrity reported


Kardium announces US$ 104 million in new financing for innovative Atrial Fibrillation Treatment
News | June 13, 2024

Kardium announces US$ 104 million in new financing for innovative Atrial Fibrillation Treatment

Private financing round supported by Fidelity Management & Research Company, T. Rowe Price and Durable Capital Partners


Abbott wins CE mark for dual-chamber leadless pacemaker
News | June 11, 2024

Abbott wins CE mark for dual-chamber leadless pacemaker

Abbott's first-of-its-kind i2i technology enables synchronized communication between two leadless pacemakers


Gavi outlines plans to support access to new vaccines
News | June 09, 2024

Gavi outlines plans to support access to new vaccines

The Gavi Board today approved the Vaccine Alliance's strategy for the five-year period running from 2026 to 2030