Latest Fda Approval News

Dimerix has received a US$10 million upfront payment from Everest Medicines under a regional licensing deal for DMX-200 targeting FSGS in Greater China, South Korea and Southeast Asia. This deal marks Dimerix’s fifth commercial partnership for DMX-200, collectively worth up to A$1.9 billion in milestones and royalties.

ReNerve Ltd (ASX:RNV) reported an 80% year-on-year revenue increase in Q4 FY26, backed by expanding product lines and a $5 million funding facility. The company is advancing FDA approvals and growing its global distribution footprint, targeting a rapidly expanding $6.19 billion nerve repair biomaterials market.

Mesoblast has treated 350 patients in its pivotal Phase 3 trial for rexlemestrocel-L, targeting chronic low back pain linked to degenerative disc disease, setting the stage for top-line results in mid-2027.

Dimerix has secured full sponsorship of the US Investigational New Drug application for its Phase 2-ready kidney drug DMX-652, setting the stage for a clinical trial targeting acute kidney injury in late 2026.

OncoSil Medical has won FDA Humanitarian Device Exemption approval for its OncoSil™ device to treat distal cholangiocarcinoma, opening a US market estimated at A$80 million annually.

Clarity Pharmaceuticals has presented compelling clinical evidence that its investigational 64Cu-SAR-bisPSMA diagnostic and 67Cu-SAR-bisPSMA therapeutic candidates outperform current standards in prostate cancer care, positioning the company for regulatory and commercial milestones.

Argent BioPharma's licensing partner Splash Beverage Group has launched the US veterinary development program for CannEpil®, targeting companion-animal oncology and chronic pain. Led by industry veteran Dr Hunter Land, the initiative follows a defined FDA regulatory pathway and could broaden CannEpil®’s commercial footprint beyond human neurology.

Lumos Diagnostics has landed a US$767,800 purchase order for its FebriDx rapid test from PHASE Scientific, marking a key step in commercialising its FDA-approved product ahead of the US flu season.

Vitrafy Life Sciences reported an 80% revenue surge and halved its net loss, buoyed by US military validation and major blood network partnerships. A $32 million capital raise fuels its US commercial expansion and manufacturing scale-up.

Clarity Pharmaceuticals bolsters its commercial readiness with a $178.3 million cash reserve and a key US manufacturing agreement, while clinical trials for its prostate cancer imaging and therapeutic agents progress with promising data.

Mesoblast delivered US$115 million in Ryoncil® revenue in its first full year post-FDA approval, while expanding clinical trials into adult indications and acquiring cutting-edge CAR technology to boost its cell therapy pipeline.

Island Pharmaceuticals has marked a major step forward in its antiviral program with the start of GMP manufacturing for Galidesivir, expanded USAMRIID collaboration, and FDA orphan drug designation. Regulatory approvals for compassionate use in Uganda’s Ebola outbreak and a new dose optimisation study with Texas Biomed further de-risk the pathway to approval.