Latest Fda Approval News

Clarity Pharmaceuticals has completed enrolment in its Phase III AMPLIFY trial for the Cu-SAR-bisPSMA imaging agent, advancing its bid for FDA approval in prostate cancer diagnostics.

Nexalis Therapeutics has initiated its Phase 1 trial for IRX-616a, an inhaled cannabidiol treatment aimed at panic disorder, marking a significant step in developing rapid-onset anxiety therapies.

Island Pharmaceuticals has entered a pivotal research agreement with USAMRIID and the Geneva Foundation to accelerate FDA approval of Galidesivir for Marburg Virus Disease, leveraging top-tier US biodefense expertise.

Botanix Pharmaceuticals reports a surge in Sofdra sales driving revenue to $16.5 million, yet the company records a $33.2 million loss amid expanded marketing and operational costs. A $45 million capital raise aims to support growth and supply chain improvements.

Mesoblast Limited reported its first commercial sales of FDA-approved Ryoncil, generating $48.7 million in net product sales for the half-year ended December 31, 2025, while reducing its net loss by 16%. The company also secured a $125 million five-year credit facility, restructuring its debt to support ongoing commercialization and development.

Neuren Pharmaceuticals reports a 15% rise in 2025 royalties from its partner Acadia’s DAYBUE sales, with strong 2026 guidance signalling further growth. The launch of a new powder formulation and ongoing regulatory efforts in Europe and Japan add to the momentum.

Artrya Limited reported a 44% increase in its half-year loss to $10.7 million as it transitioned from development to commercial operations in the US, securing FDA clearance and signing three foundation customers. An $80 million capital raise underpins its ambitious US expansion and ongoing product development.

Cyclopharm Limited reported a 17% revenue increase to a record $32.3 million in 2025, powered by a 226% surge in US Technegas sales. The company is accelerating its US rollout with plans for up to 300 installations in 2026, while advancing clinical trials beyond pulmonary embolism.

Cleo Diagnostics reported a 53% drop in revenues and a slight increase in net loss to $1.98 million for H1 2025, while progressing its pivotal FDA clinical trial for an ovarian cancer blood test with strong regulatory and commercial milestones.

Immuron Limited reported a narrower half-year loss alongside record sales growth and FDA approval for its IMM-529 drug candidate, signalling promising clinical and commercial momentum.

Epiminder Limited has reported a $21.7 million loss for the half-year ending December 2025, alongside a successful $125 million IPO that fuels its commercialisation of the FDA-approved Minder epilepsy monitoring device.

Imricor Medical Systems saw a sharp 69.5% decline in revenue for 2025, driven by clinical trial impacts, yet narrowed its net loss to $25.3 million as it secured FDA clearance for key products post-year-end.