Latest Fda Approvals News

Cleo Diagnostics has gained approval to access the prestigious PLCO biobank, a move set to strengthen its FDA submission and accelerate development of its ovarian cancer diagnostic tests.

PYC Therapeutics has gained FDA alignment on the design of its pivotal Phase 2/3 trial for VP-001, a promising treatment for the rare childhood blindness RP11. The regulator accepted the trial’s sham control arm and primary endpoints, setting the stage for a critical next step toward drug approval.

Optiscan Imaging Ltd has entered a five-year exclusive collaboration with Long Grove Pharmaceuticals to jointly develop new clinical applications for the fluorescein drug AK-FLOUR®, supporting US clinical trials and FDA regulatory submissions for Optiscan’s InVue® surgical device.

EZZ Life Science has launched its US-focused brand EZZDAY with four FDA-registered supplements, marking a major step in its international growth strategy. The company has also begun US-based manufacturing and opened an online store to target American consumers.

Lumos Diagnostics has enrolled 500 patients in its FebriDx CLIA waiver clinical study, unlocking a significant milestone payment from BARDA and moving closer to FDA approval that could open a US$1 billion market.

Clarity Pharmaceuticals has partnered with SpectronRx to manufacture and distribute its lead prostate cancer diagnostic, Cu-64 SAR-bisPSMA, at commercial scale across the US. This agreement sets the stage for a seamless launch pending FDA approval.

4DMedical has renewed and expanded its contract with Stanford University’s 3DQ Lab to include its innovative CT – VQ™ imaging technology ahead of FDA clearance, marking a significant step in its U.S. market expansion.

CSL has secured FDA approval for ANDEMBRY®, a pioneering treatment for hereditary angioedema, enabling an immediate US launch with promising clinical results. This milestone marks a significant advance in managing a rare but debilitating condition.

Artrya Limited has submitted a pivotal FDA 510(k) application for its AI-powered Salix® Coronary Plaque module, aiming for clearance in Q3 2025 and a lucrative US commercial launch.

Bubs Australia has submitted critical clinical trial data to the US FDA, marking a pivotal step toward permanent approval for its infant formulas in the US market.

Mesoblast reports positive FDA progress on accelerated approval for Revascor in ischemic heart failure and plans a pivotal trial to extend Ryoncil’s label to adults with graft versus host disease, while its US commercial launch outpaces expectations.

Cleo Diagnostics unveils a pioneering blood test for early ovarian cancer detection, boasting superior accuracy to existing methods and targeting a significant U.S. market opportunity.