Latest Fda News

PYC Therapeutics reports solid progress across its four RNA therapeutic programs targeting genetic diseases, backed by a strong cash position extending runway beyond 2027.

Mesoblast has reported a strong commercial debut for Ryoncil, the first FDA-approved mesenchymal stromal cell therapy for pediatric steroid-refractory acute graft-versus-host disease, generating US$13.2 million in gross revenue in its initial quarter. The company is advancing regulatory and clinical milestones while expanding insurance coverage across the US.

4DMedical has renewed its three-year contract with the University of Michigan Medical Center, reinforcing its foothold in US respiratory imaging. Alongside, a pivotal clinical study validates its technology’s ability to detect early lung disease, while a substantial Australian grant boosts its AI research.

Lumos Diagnostics has locked in a A$5 million secured loan facility to support working capital as it advances toward FDA CLIA waiver for its FebriDx® test, complementing a landmark US distribution deal.

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.

Imugene Limited has launched a A$37.5 million capital raising to advance its promising off-the-shelf CAR T therapy, azer-cel, following encouraging Phase 1b data showing a 75% overall response rate in lymphoma patients.

Lumos Diagnostics has inked a landmark six-year exclusive distribution agreement with PHASE Scientific for its FebriDx® rapid diagnostic test in the US, potentially unlocking nearly half a billion Australian dollars in revenue contingent on FDA approval.

ImpediMed has doubled its US unit sales in Q4 FY25, achieving a record total contract value and securing an additional $5 million tranche under its growth capital facility.

Prescient Therapeutics has initiated its first US clinical site for the PTX-100 Phase 2a trial targeting Cutaneous T-Cell Lymphoma, marking a key milestone in expanding patient recruitment beyond Australia.

Imagion Biosystems has received encouraging feedback from the FDA on its MagSense HER2 breast cancer imaging program, clearing the path for a Phase 2 clinical trial and fast-tracking manufacturing.

Prescient Therapeutics has extended its Share Purchase Plan closing date to 22 July 2025, aiming to raise up to A$7 million to advance its targeted cancer therapy PTX-100 through Phase 2 clinical trials.

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.