Telix Pharmaceuticals Limited (ASX:TLX) (NASDAQ:TLX) has announced an agreement with the United States Food and Drug Administration (FDA) regarding the resubmission of its New Drug Application (NDA) for TLX101-CDx (Floretyrosine F18 or 18F-FET, Pixclara®). The investigational agent is designed for imaging glioma, a rare …
Osteopore Limited (ASX:OSX), an Australian-Singaporean regenerative medicine company, has entered into a co-development collaboration with Tan Tock Seng Hospital (TTSH) for the design of a novel implant aimed at treating avascular necrosis (AVN) of the hip joint. The project will be led by Dr …
4DMedical Limited (ASX:4DX), a global provider of advanced respiratory imaging solutions, has entered into agreements with a leading pharmaceutical company, Royal Melbourne Hospital, and Spectrum Medical Imaging. The collaborations aim to expand lung health screening, enhance diagnostic insights, and support the rollout of Australia’s …
Memphasys Limited (ASX:MEM), a reproductive biotechnology company, has entered into a five-year exclusive commercial distribution agreement with International Technical Legacy (ITL) of Doha, Qatar. The deal covers distribution of Felix™, Memphasys’ male fertility sperm preparation system, across 15 countries in the Middle East and …
PolyNovo Limited (ASX:PNV) has outlined the potential impact of the proposed changes to U.S. Medicare reimbursement for outpatient wound care, as detailed in a 31 August 2025 article byThe Australian. The reforms, announced by the U.S. Centers for Medicare & Medicaid Services (CMS), aim …
4DMedical Limited (ASX:4DX), a developer of advanced respiratory imaging technologies, announced that its ventilation-perfusion product CT:VQ™ has received clearance from the U.S. Food and Drug Administration (FDA) under the 510(k) pathway. The approval establishes CT:VQ™ as the first non-contrast, CT-based imaging solution capable of …
Lumos Diagnostics Holdings Ltd (ASX:LDX), a developer of rapid point-of-care diagnostic technologies, has signed a follow-on contract with Aptatek Biosciences, Inc. (Aptatek), a New Jersey-based biotechnology company, to advance the PheCheck™ aptamer-based monitoring tool for phenylketonuria (PKU).
Clinuvel Pharmaceuticals Ltd (ASX: CUV) shares came under pressure on Friday following the release of its FY25 results, despite the company reporting another year of profit. The ASX 300 healthcare stock closed yesterday at AUD 12.53 but fell as much as 16% in early …
Ramsay Health Care Limited (ASX:RHC) has announced its financial results for the year ended 30 June 2025. The group reported a net profit after tax (NPAT) and minority interests of AUD 24.0 million. This figure incorporates a negative contribution of AUD 281.3 million from …
Integral Diagnostics Limited (ASX:IDX), a leading provider of diagnostic imaging services across Australia and New Zealand, has received a series of favorable analyst recommendations following the release of its full-year results for the 12 months ended 30 June 2025 (FY25).