Latest Fda Approvals News

Mesoblast Limited (ASX:MSB, Nasdaq:MESO) reported net sales of US$30.3 million for its FDA-approved cellular therapy Ryoncil in the March quarter, bringing total revenue since launch close to US$100 million. Strong sales in February and March offset January’s seasonal dip.

AVITA Medical has lodged a new $200 million shelf registration with the SEC, renewing its capacity to issue various securities in the US market. While no immediate capital raising is planned, this move preserves the company’s financial agility for future growth opportunities.

Patrys Limited is advancing a proprietary injectable formulation of quetiapine aimed at the large and underserved delirium treatment market, leveraging an accelerated FDA approval pathway and extensive existing safety data.

Botanix Pharmaceuticals has successfully renegotiated its API supply agreement, deferring significant purchases to later years and strengthening its financial position ahead of Sofdra's market rollout.

4DMedical’s advanced lung imaging technology CT:VQ™ has been deployed at the Mayo Clinic, marking the sixth top US academic medical centre to adopt the system within seven months of FDA clearance.

Clarity Pharmaceuticals has signed a significant manufacturing supply agreement with Theragenics to produce copper-64, a key isotope for its upcoming prostate cancer diagnostic, Cu-SAR-bisPSMA. This deal strengthens Clarity’s US supply network ahead of anticipated FDA approval and commercial launch.

BlinkLab has enrolled its first participant in the pivotal FDA 510(k) validation study for its autism diagnostic aid, BlinkLab Dx1, aiming for regulatory submission by the end of 2026.

BlinkLab’s smartphone-based Dx1 autism screening technology has been selected for Morocco’s government-funded national early screening program, marking a major milestone in digital health adoption and autism care.

Cleo Diagnostics has expanded its ovarian cancer biomarker panel from five to eight markers, enhancing test reliability and gearing up for FDA submission. A manufacturing deal is imminent, setting the stage for commercial rollout.

EBR Systems marked a pivotal transition in 2025 with FDA approval of its WiSE CRT System and the initiation of U.S. commercial implants, generating $1.6 million in revenue. Despite this progress, the company reported a net loss of $48.8 million and completed a significant capital raise to support ongoing growth.

Clarity Pharmaceuticals has unveiled compelling Phase II trial results showing its Cu-SAR-bisPSMA PET imaging agent significantly improves detection of prostate cancer recurrence over the current standard. The data, presented at the 2026 European Association of Urology Congress and accepted by European Urology journal, mark a key milestone ahead of regulatory submissions.

Telix Pharmaceuticals has resubmitted its New Drug Application to the FDA for TLX101-Px (Pixclara®), aiming to advance a novel PET imaging agent for glioma diagnosis. The resubmission addresses prior regulatory concerns with additional data, reinforcing hopes for expedited approval.