Latest Fda News

Vitasora Health has secured AU$3.56 million from a cornerstone investor, issuing over 118 million shares, while confirming compliance with key regulatory disclosure obligations.

Immutep Limited reveals promising Phase II results from its AIPAC-003 trial, establishing 30 mg as the optimal biological dose of eftilagimod alfa combined with paclitaxel in metastatic breast cancer patients.

Imagion Biosystems is set to submit its Investigational New Drug application for the MagSense® HER2 breast cancer imaging agent in December 2025, paving the way for a Phase 2 clinical trial in early 2026. Collaboration with Wayne State University has refined the trial design, promising improved patient safety and diagnostic precision.

Singular Health has submitted a 510(k) premarket notification to the FDA for its enhanced 3DICOM MD Cloud platform, aiming to expand imaging capabilities and introduce a scalable, cloud-native solution for medical image management.

SomnoMed Limited reported a robust FY25 with revenue surpassing guidance and a landmark FDA clearance for its Rest Assure® oral device, setting the stage for sustained growth in oral appliance therapy.

Recce Pharmaceuticals has secured a key patent in Hong Kong for its synthetic anti-infectives, reinforcing its intellectual property footprint in Asia and supporting its clinical and commercial ambitions in the region.

ReNerve Ltd reports a strong 53% year-on-year revenue increase, expanding its US distribution network and advancing clinical studies for its nerve repair products. The company is poised for significant global market growth with new partnerships and upcoming product launches.

Adherium Limited has reached a pivotal commercial milestone by expanding its Remote Patient Monitoring program across 110 U.S. Allergy Partners clinics, activating nearly 70% of the network and onboarding close to 700 patients in six months.

InhaleRX Limited has announced a non-renounceable entitlement offer to raise approximately $247,668 by issuing nearly 10 million new shares at 2.5 cents each, accompanied by free attaching options. The offer opens on 5 December and closes on 17 December 2025.

InhaleRx Limited has introduced SRX-25, an oral fixed-dose combination therapy targeting Treatment-Resistant Depression, aiming to improve patient access and adherence. The company also secured $1 million in capital to advance clinical development and plans a strategic rebrand.

PainChek Ltd has secured FDA De Novo clearance for its Adult App, marking a pivotal entry into the US long-term care market and setting the stage for global expansion including its Infant App.

Recce Pharmaceuticals has reported compelling preclinical results for its inhaled anti-infective RECCE 327, demonstrating potent activity against multidrug-resistant pneumonia bacteria in mice models.