The commercialisation of osteoarthritis treatment ZILOSUL® has hit a hiccup in the United States with the US Food and Drug Administration (FDA) raising fresh questions to late-stage drug development company, Paradigm Biopharmaceuticals (ASX: PAR). The FDA response related to Paradigm’s application for Investigational New Drug status to be granted for their focus compound, Pentosan Polysulfate
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While Americans battle to manage an array of health concerns sweeping the elderly, hearing loss may not be one of them with medtech company Nuheara (ASX: NUH) granted US Food and Drug Administration (FDA) approval for its new wireless hearing aid, IQbuds² PRO. The PRO version expands the Company’s range of wireless, low cost hearing
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Aussie pharmaceuticals company Acrux (ASX: ACR) is quickly making inroads through the lucrative American healthcare system with regulatory approval granted for their generic equivalent of a common testosterone topical solution which generates more than $25 million annually. Approval was granted from the Food and Drug administration for Acrux’s gel following their submission in August 2018
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Biopharma company Imugene (ASX: IMU) is now on their way towards commercialisation of their lung cancer treatment with approval from the US Food and Drug Administration (FDA) to commence human trials. With the project name PD1-Vaxx in the US, the approval enables Imugene to commence recruiting patients for a clinical trial of the treatment on
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Medical imaging and research company Resonance Health (ASX: RHT) continues to advance a new artificial intelligence solution for automated alerts for patients with a suspected pulmonary embolism (PE), blood clots that block arteries in the lungs. The research and development has now led to the Pre-Submission filing of ALERT-PE to the United States Food and
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Pharmaceuticals developer Acrux (ASX: ACR) is set to expedite commercialisation of its generic topical products in the United States via the appointment of TruPharma as their exclusive sales, marketing and distribution partner in America. The agreement will see TruPharma take over responsibility for getting Acrux products approved by the U.S Food and Drug Administration (FDA)
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