Latest Fda News

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.

Island Pharmaceuticals has completed its acquisition of the broad-spectrum antiviral Galidesivir ahead of schedule, setting sights on expedited FDA approval leveraging the Animal Rule.

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.

Zelira Therapeutics reports promising diabetic neuropathy study results with ZLT-L-007 surpassing Lyrica, while converting $3.25 million in notes to equity to bolster HOPE® 1 clinical development.

Alterity Therapeutics has secured U.S. FDA Fast Track designation for its drug ATH434 targeting Multiple System Atrophy, supported by promising Phase 2 clinical trial data showing slowed disease progression and a solid safety profile.

Syntara Limited reports encouraging Phase 2 data for its lead drug amsulostat in myelofibrosis, secures FDA Fast Track status, and expands clinical programs into myelodysplastic syndrome and keloid scars.

CurveBeam AI reported a solid 18% increase in purchase orders for FY25, alongside record cash receipts and positive operational cash flow in Q4. The company is also advancing a significant vendor financing facility to support growth in key markets.

Prescient Therapeutics has secured FDA Fast Track designation for PTX-100 in treating relapsed Cutaneous T-Cell Lymphoma and dosed the first patient in its Phase 2a trial, supported by a recent $6.8 million capital raise.

CurveBeam AI reported a strong Q4 FY25 with record customer receipts and an 18% rise in purchase orders, while advancing key regulatory milestones and securing a major financing facility.

Neurizon Therapeutics has made significant strides in developing its lead ALS drug candidate NUZ-001, unveiling a new liquid formulation and submitting a key regulatory response to the FDA. Clinical and preclinical data bolster hopes for broader neurodegenerative applications.

dorsaVi has acquired exclusive global rights to advanced RRAM technology, promising major performance gains in its biomedical sensors, while securing key contracts and raising $2.44 million to fuel US market growth.

Acrux Limited reports promising revenue growth driven by new topical generic launches in the US and secures crucial RDTI funding, marking a strategic shift under new CEO John Warmbrunn.