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FDA

Q&A: Paradigm to answer FDA questions to achieve Investigational New Drug status

The commercialisation of osteoarthritis treatment ZILOSUL® has hit a hiccup in the United States with the US Food and Drug…

4 years ago

Nuheara receives FDA registration for newest wireless hearing aids

While Americans battle to manage an array of health concerns sweeping the elderly, hearing loss may not be one of…

4 years ago

Quickfire FDA approval for Acrux’s testosterone sends share price soaring

Aussie pharmaceuticals company Acrux (ASX: ACR) is quickly making inroads through the lucrative American healthcare system with regulatory approval granted…

5 years ago

FDA approves Imugene to commence human trial for lung cancer immunotherapy

Biopharma company Imugene (ASX: IMU) is now on their way towards commercialisation of their lung cancer treatment with approval from…

5 years ago

Resonance Health preparing FDA submission for pulmonary embolism AI alerts

Medical imaging and research company Resonance Health (ASX: RHT) continues to advance a new artificial intelligence solution for automated alerts…

5 years ago

Acrux shares surge 37% on appointment of U.S pharmaceuticals distributor

Pharmaceuticals developer Acrux (ASX: ACR) is set to expedite commercialisation of its generic topical products in the United States via…

5 years ago