Biotech company Mesoblast (ASX: MSB) has received positive feedback from the US Food and Drug Administration (FDA) for a new heart failure treatment called rexlemestrocel-L. This treatment aims to help people with severe heart failure, particularly those who have reached the end stages of the condition. Heart failure affects millions of people worldwide, with many
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With its cash reserves dwindling, digital health company Advanced Health Intelligence (ASX: AHI) is having to make a strong case for itself among shareholders. One of its bigger moves is the US FDA submission of July 2023. The purpose of an FDA Section 513(g) submission is to obtain clarification on the regulatory pathway for a
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Clinical state oncology company Prescient Therapeutics (ASX: PTX) has received the US FDA’s Orphan Drug Designation for its PTX-100 drug, used for cancer treatment. Previously, the Company received ODD for peripheral T-cell lymphomas (PTCL) in 2022. Following that, it applied for ODD for cutaneous T-cell lymphomas (CTCL), and it was granted a blanket designation for
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Maxigesic’s tagline goes: Put it to the test for your pain. Its maker—pharma company AFT Pharmaceuticals (ASX: AFP) —did indeed put the med to the test, and it came out as a winner, bagging FDA’s approval. Sort of like a super tablet, Maxigesic combines the powers of ibuprofen and paracetamol to create a super powerful
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Clinical trials are an essential part of the drug development process and play a critical role in determining the safety and efficacy of new treatments. However, understanding how clinical trials operate can be one of the more difficult concepts to grasp for investors when looking to invest in medical research, drug or device development in
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Drug development company NeuroScientific Biopharmaceuticals Ltd (ASX: NSB) is not ready to give up on EmtinB, its trademark drug that didn’t make it past the Human Research Ethics Committee (HREC) and resulted in the Company’s previous CEO resigning. Remaining undeterred, it has filed a new patent, entitled “Neuroprotective compositions and methods”, that will use a
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