Latest Us Fda News

Imricor Medical Systems reports significant regulatory approvals and clinical trial progress, positioning itself as a disruptive force in the growing electrophysiology market. With a strengthened commercial pipeline and solid cash reserves, the company is poised for a pivotal growth phase.

Invion Limited has disclosed that the US FDA granted Orphan Drug Designation for its lead cancer drug candidate INV043, explaining recent unusual trading activity in its shares. The company confirmed it was unaware of the FDA decision prior to its public release and has now complied with continuous disclosure rules.

IDT Australia announces the immediate resignation of CEO Paul McDonald, appointing Executive Chair Mark Simari to lead as the company reports a 40.6% revenue increase but a widening net loss for FY25.

Optiscan Imaging Ltd has launched its first in-human breast cancer study and unveiled a new veterinary imaging device, while securing a key US collaboration to support FDA submissions.

Clarity Pharmaceuticals has bolstered its cash reserves to approximately $288 million following a $203 million institutional placement, while reporting significant clinical progress across multiple copper-based radiopharmaceutical trials targeting prostate cancer and neuroendocrine tumours.

Prescient Therapeutics has raised nearly $10 million through a placement and share purchase plan to advance its promising PTX-100 targeted cancer therapy into pivotal clinical stages.

Imugene Limited reports strong clinical progress with its off-the-shelf CAR T therapy azer-cel achieving a 75% overall response rate in Phase 1b trials, alongside new patents and leadership appointments. The company also secured $22.5 million in fresh funding to advance pivotal trials.

Acrux Limited has secured a decade-long licensing agreement with Servacure to commercialise its FDA-approved Dapsone 5% Gel in Saudi Arabia, marking a strategic step in its global expansion.

PainChek Limited has secured a A$7.5 million placement to fuel its international expansion, with US FDA clearance for its adult pain assessment app expected imminently. The company reports strong license growth and a 26% revenue increase year-on-year.

Percheron Therapeutics has licensed HMBD-002, a promising immuno-oncology candidate, completed FDA IND transfer, and plans to launch phase II trials in 2026. The company also reported a solid cash position and issued loyalty options to shareholders.

PainChek Limited has raised A$7.5 million through a strongly supported placement to accelerate its US market entry following anticipated FDA clearance and expand its innovative AI pain assessment technology internationally.

Bubs Australia Limited reports a strong FY25 with 29% revenue growth to $102.5 million, positive EBITDA turnaround, and sustained cash flow improvements. The company also advances its US market ambitions with a key FDA submission underway.