Latest Fda Approvals News

LTR Pharma highlights SPONTAN's 5x faster absorption and validated safety, backed by over 1,000 Australian prescriptions and strategic partnerships as it targets FDA approval and US market entry.

Clarity Pharmaceuticals’ Phase II Co-PSMA trial confirms its Cu-SAR-bisPSMA PET imaging detects more than twice the prostate cancer lesions versus standard care, driving patient management changes. Phase III AMPLIFY recruitment closes, manufacturing deals inked, and cash sits near $198 million.

Mesoblast Limited posted US$30.3 million in net revenues for Ryoncil® in Q3 2026, hitting key clinical milestones and securing new technology licenses that could boost its next-generation cell therapies.

Dimerix has completed adult patient recruitment in its Phase 3 ACTION3 trial for DMX-200, with a blinded review confirming the study remains statistically powered to demonstrate treatment efficacy. The company also appointed a new CFO and is negotiating up to US$50 million in non-dilutive funding.

Acrux pivots from generics to developing a Female Testosterone therapy for HSDD, leveraging FDA feedback and a strong US market opportunity.

LTR Pharma has wrapped up recruitment for its SPONTAN Phase II pharmacokinetic study, with interim results expected soon to bolster FDA approval efforts. Meanwhile, US commercial talks for ROXUS advance cautiously under the FDA 503(a) personalised medicine pathway.

Cleo Diagnostics has kicked off a staged manufacturing program with Bio-Techne to produce ovarian cancer test kits, moving from clinical sample collection to analytical validation and FDA submission preparation.

Imricor Medical Systems updates its SEC Form 10 with minor SEC-driven revisions as it pushes forward with FDA clearances and clinical trials, reporting a $25.3 million net loss in 2025 amid early-stage commercialisation.

The FDA has removed the postmarketing cardiac repolarization study requirement for Clinuvel's SCENESSE®, reflecting confidence in its long-term safety profile. This marks a regulatory milestone for the only approved treatment for erythropoietic protoporphyria in the US.

EBR Systems secures Priority Review from Australia's TGA for its wireless cardiac pacing system, fast-tracking regulatory approval and expanding access for heart failure patients. This follows strong US commercial momentum after FDA approval.

4DMedical lands a contract with pharma giant GSK, gains UKCA certification for its CT:VQ™ lung imaging technology, and joins the S&P/ASX 200, marking a significant step in its global expansion.

Atomo Diagnostics has responded to ASX queries confirming it first held market-sensitive information after Lumos Diagnostics’ FDA CLIA waiver approval for FebriDx. The company defended its trading halt and capital raise timing, asserting full compliance with ASX Listing Rules.