Latest Fda News

Anteris Technologies has completed a $90 million strategic investment from Medtronic as part of a $320 million capital raise, advancing its DurAVR transcatheter heart valve towards global commercialisation and pivotal clinical trials.

Cambium Bio has strengthened its financial footing with a $0.6 million R&D tax refund and a $2.4 million strategic placement, setting the stage for pivotal Phase 3 clinical trials of its lead ophthalmology candidate.

Arovella Therapeutics has filed an IND application for its lead CAR-iNKT therapy ALA-101, selected a CRO for its upcoming phase 1 trial, and secured $19.4 million in cash to fund clinical progress and pipeline expansion.

PYC Therapeutics has reported significant progress across its four RNA therapeutic programs targeting rare genetic diseases, supported by a strong cash position of $121 million at the end of 2025. Key clinical milestones and regulatory plans set the stage for upcoming trial readouts and potential market entry.

Anteris Technologies Global Corp. has launched a $230 million equity offering alongside an $84 million private placement with Medtronic’s subsidiary, aiming to accelerate clinical trials and scale manufacturing of its innovative DurAVR Transcatheter Heart Valve.

LTR Pharma has initiated dosing in its Phase II clinical trial for SPONTAN, a rapid-acting intranasal spray targeting erectile dysfunction, marking a key step toward FDA approval and commercial expansion.

Imricor Medical Systems has secured Virginia Commonwealth University Health as the third US site for its VISABL-AFL clinical trial, advancing its FDA approval pathway for MRI-guided cardiac ablation technology.

AdAlta Limited has aligned its AdCella manufacturing strategy with new US FDA guidelines, made a significant milestone payment to Shanghai Cell Therapy Group, and secured an additional R&D tax rebate, marking key progress in its cellular immunotherapy pipeline.

Atomo Diagnostics has locked in exclusive global rights to a novel liver function test that rapidly detects liver injury, expanding its footprint in point-of-care diagnostics. The test, delivered on Atomo’s Pascal platform, targets drug-induced liver injury and chronic liver conditions with significant commercial potential.

Cambium Bio has locked in a A$2.4 million strategic investment from Zheng Yang Biomedical Technology, reinforcing its push into pivotal Phase 3 trials for its dry eye disease treatment.

Mesoblast has received encouraging feedback from the FDA on its cell therapy rexlemestrocel-L, showing meaningful pain relief and potential opioid use reduction in chronic low back pain patients. The company’s ongoing Phase 3 trial aims to confirm these benefits and advance regulatory approval.

4DMedical Limited has raised AU$150 million to accelerate the commercial rollout of its FDA-cleared CT, VQ lung imaging technology in the US, leveraging a strategic partnership with Philips. This funding aims to expand adoption across major medical centres and government healthcare programs.