Latest Fda News

BlinkLab has launched its pivotal FDA registrational study for its AI-driven autism diagnostic app, BlinkLab Dx 1, following positive FDA feedback and promising preliminary results.

Zelira Therapeutics has secured a fourth funding tranche of US$681,000, advancing its HOPE® Autism Spectrum Disorder FDA trial process and bringing total funding to US$3.25 million. The company is progressing clinical validation and product development, including the transformation of Zenivol® into a capsule formulation.

Echo IQ Limited has secured FDA clearance for its EchoSolv AS technology and appointed a US-based CEO, marking a pivotal shift towards commercialisation in the American healthcare market.

Argenica Therapeutics has dosed 80% of patients in its Phase 2 stroke trial and gained FDA orphan drug designations for its second candidate, ARG-006. The company reports a cash-positive quarter with $15 million in reserves.

Alterity Therapeutics has announced encouraging Phase 2 trial results for ATH434, showing significant slowing of disease progression in multiple system atrophy (MSA) patients and a strong safety profile. These findings mark a potential breakthrough in treating a disease with no approved therapies.

NeuroScientific Biopharmaceuticals has initiated critical IND-enabling studies for its glaucoma drug candidate EmtinB, backed by a solid cash position of A$4.5 million as of December 2024. Preliminary melanin binding results are shaping the path toward first-in-human trials.

Imagion Biosystems has secured a AU$3 million capital injection and resumed its collaboration with Siemens, setting the stage to prioritize FDA filings and advance its MagSense® HER2 breast cancer imaging program.

LTR Pharma reports compelling clinical results for its nasal spray ED treatment SPONTAN®, demonstrating rapid absorption and strong safety, alongside strategic partnerships and a robust $34 million cash position.

Island Pharmaceuticals reports promising safety and anti-dengue activity in its Phase 2a trial of ISLA-101 and has commenced the Phase 2b therapeutic arm, backed by a fresh A$3.5 million capital raise.

Starpharma reports encouraging FDA feedback on its DEP® SN38 candidate for ovarian cancer and prepares for product launches in Saudi Arabia and UAE, supported by a solid $20.3 million cash position.

ReNerve Limited has reported a remarkable 260% increase in quarterly sales following its successful IPO, alongside strategic distribution deals in Hong Kong and the Middle East. The company is poised for further growth with upcoming clinical data and product developments.

Artrya Limited reports solid progress on its FDA 510(k) application and secures a A$5 million capital raise, positioning itself for imminent commercial rollout in the US healthcare sector.