Latest Fda Approvals News

EBR Systems has completed the first patient implant in its Totally Leadless CRT (TLC-AU) feasibility study, marking a strategic step toward expanding wireless cardiac resynchronisation therapy for heart failure patients.

EBR Systems has expanded its intellectual property holdings with four new patents, reinforcing its lead in wireless cardiac pacing technology, while facing a preliminary setback on a patent term extension application.

Neurizon Therapeutics has secured FDA clearance for its lead drug candidate NUZ-001 to enter the HEALEY ALS Platform Trial, marking a key regulatory milestone and setting the stage for patient enrollment in early 2026.

InhaleRx advances its clinical pipeline with a new oral treatment for resistant depression and plans a strategic rebrand to Nexalis Therapeutics, signaling a broader focus beyond inhaled therapies.

Anteris Technologies has secured regulatory green lights for its pivotal PARADIGM trial and raised $25.2 million in capital, advancing its innovative DurAVR® transcatheter heart valve towards commercialisation.

Island Pharmaceuticals has submitted critical responses to the FDA, advancing the development of its antiviral Galidesivir under the Animal Rule pathway. The company awaits FDA feedback expected by early January 2026, setting the stage for upcoming Marburg virus studies.

Island Pharmaceuticals has secured over $1 million through option exercises by directors and major shareholders, bolstering its cash reserves to advance the clinical and regulatory development of its broad-spectrum antiviral, Galidesivir.

Optiscan Imaging Ltd has initiated Australia’s first intra-operative head and neck cancer imaging study using its advanced InVue® and InForm™ devices, aiming to enhance surgical precision and support FDA regulatory submissions.

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.

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.

Anteris Technologies Global Corp. has filed a Form S-1 registration statement with the SEC to enable resale of shares issued in a recent private placement, marking a key step in advancing its DurAVR transcatheter heart valve system and pivotal clinical trials.

Cleo Diagnostics has secured a $1.7 million R&D tax refund, strengthening its cash reserves to $5.75 million as it advances toward a pivotal US clinical trial and FDA submission for its ovarian cancer test.