Latest Fda News

Island Pharmaceuticals has submitted a detailed briefing to the FDA aiming to accelerate approval of its antiviral Galidesivir for Marburg virus under the Animal Rule, with feedback expected by November.

EMVision Medical Devices launches a $2 million Share Purchase Plan offering shares at a 16.4% discount, bundled with free options exercisable at $3.40, aiming to bolster clinical and commercial milestones.

Recce Pharmaceuticals has initiated patient dosing in its pivotal Phase 3 trial for diabetic foot infections in Indonesia, targeting a significant market with high diabetes prevalence. Interim results expected in early 2026 could accelerate regulatory approval and commercial launch.

Race Oncology has secured Investigational New Drug approval from South Korea’s regulatory authority, enabling Phase 1 clinical trials of RC220 in combination with doxorubicin for solid tumour patients across four Korean sites.

EMVision Medical Devices has initiated a unique pre-hospital study in Melbourne to test its First Responder Brain Scanner within one of the world’s few Mobile Stroke Units, aiming to enhance stroke diagnosis and accelerate commercialisation.

Telix Pharmaceuticals secures Transitional Pass-Through payment status for its next-generation prostate cancer imaging agent Gozellix, paving the way for broader US patient access and streamlined provider reimbursement.

Arovella Therapeutics has received a $3.21 million R&D tax incentive refund, bolstering its financial position as it prepares to initiate first-in-human trials for its lead cell therapy, ALA-101.

The European Medicines Agency has approved continuous bi-monthly dosing of CLINUVEL’s SCENESSE® for adult erythropoietic protoporphyria patients, removing previous annual dose limits and aligning Europe with US treatment standards.

ReNerve Limited has launched its Empliq tissue product range in the US, marking a strategic expansion into the growing dermal and amniotic tissue market. The launch complements its existing nerve repair portfolio and sets the stage for further growth.

Echo IQ has completed its presentation to the CPT Editorial Panel for a Category III CPT code for EchoSolv AS, with a decision expected from the American Medical Association in the coming weeks. Meanwhile, the company is advancing US deployments and FDA clearance efforts.

Island Pharmaceuticals has won a crucial FDA Type C meeting to discuss fast-tracking its antiviral Galidesivir for Marburg virus treatment, with written feedback expected by November.

Neurizon Therapeutics has raised $5 million through an institutional placement to advance its lead ALS drug candidate NUZ-001 into a pivotal clinical trial, pending FDA clearance. The capital injection also supports manufacturing and pre-clinical development efforts.