Latest Fda News

Mesoblast has drawn US$50 million from a new five-year facility that reduces its interest burden and retires expensive short-term debt, strengthening its financial position ahead of commercial expansion.

Imagion Biosystems has raised $3.75 million to fund the start of its Phase 1b/2 clinical trial for the MagSense HER2 imaging agent in the US, following FDA clearance. The capital raising involves a two-tranche share placement with free attaching options, led by CPS Capital.

Echo IQ has locked in a binding Heads of Agreement with Pro Medicus for a strategic A$20 million investment and a US commercial partnership to accelerate adoption of its AI-powered cardiac diagnostic platform.

AFT Pharmaceuticals surged 22% to NZ$254.7 million revenue in FY26, surpassing profit guidance and securing FDA approval to advance a pivotal injectable iron Phase III trial targeting a $7.4 billion market. The company is poised for further global expansion and product launches in FY27.

CONNEQT Health has lodged an FDA Pre-Submission for SphygmoCor Cloud, aiming to shift its arterial health analytics from hardware to a scalable software platform with broad commercial potential.

Recce Pharmaceuticals has secured ethics approval to upgrade and broaden its pivotal Phase 3 trial of RECCE® 327 Topical Gel for diabetic foot infections in Australia, accelerating recruitment and reinforcing its global registration ambitions.

Island Pharmaceuticals has won a key regulatory boost as the US FDA granted Orphan Drug Designation to Galidesivir for post-exposure prophylaxis of Marburg virus disease, enhancing its commercial and development prospects.

Island Pharmaceuticals has presented encouraging Phase 2a results for its dengue antiviral ISLA-101, demonstrating safety, effective blood concentrations, and meaningful viral load reductions at the Asia Dengue Summit.

CLINUVEL Pharmaceuticals has lodged its Form 20-F with the U.S. SEC, seeking to elevate its American Depository Receipt program to a Nasdaq-listed American Depository Share, aiming to boost visibility and liquidity without raising capital.

LTR Pharma has confirmed it disclosed a binding US commercialisation agreement for ROXUS promptly after signing, responding to ASX scrutiny over pre-announcement trading activity.

Vitrafy Life Sciences has secured A$30 million through an institutional placement to ramp up manufacturing of its Guardion cryopreservation devices and expand US sales operations, with an additional A$2 million sought via a shareholder plan.

Echo IQ has partnered with Mayo Clinic to assess its AI platform's ability to predict heart failure risk in patients undergoing cancer therapy, targeting the growing cardio-oncology sector.