Latest Us Fda News

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.

Amplia Therapeutics has launched a $27.5 million capital raising to advance its lead drug Narmafotinib, a promising FAK inhibitor showing superior efficacy in pancreatic cancer trials. The funds will support ongoing and new clinical studies, positioning the company for pivotal regulatory milestones.

NeuroScientific Biopharmaceuticals has completed its acquisition of StemSmart technology, reporting promising clinical results in Crohn’s disease and GVHD, alongside a $3.5 million capital raise to fuel next-stage development.

Tetratherix Limited has marked a pivotal quarter with a $25 million ASX listing, an exclusive licensing agreement with Bio Optix for ophthalmic devices, and progress on FDA regulatory submissions for its prostate spacer product.

IDT Australia has signed a memorandum with NASDAQ-listed Gelteq to establish a dedicated gel-based product manufacturing facility, marking a strategic expansion in pharmaceutical delivery technologies.

INOVIQ Limited reports strong clinical validation for its EXO-OC ovarian cancer screening test and promising preclinical results for CAR-exosome therapeutics targeting aggressive cancers.