Latest Fda Approvals News

Bubs Australia expects FY26 revenue between $105 million and $115 million, with underlying EBITDA forecast at $4 million to $8 million despite external challenges including regulatory delays and increased air freight costs.

Immuron Limited has responded to an ASX price query following a sharp rise in its share price and trading volume, confirming no undisclosed information but pointing to a recent CEO presentation as a possible driver.

Osteopore has secured Hainan FDA approval to clinically use and sell its custom orthopaedic devices at Shanghai Ruijin Hospital’s Hainan branch, marking a key step towards wider China market access. The company has scheduled its first patient surgery for June 2026.

Vitrafy Life Sciences has achieved a major validation milestone with US Army-backed Phase II results showing its no-wash platelet cryopreservation protocol delivers 94% post-thaw recovery, outperforming existing standards and advancing FDA registration plans.

AFT Pharmaceuticals posted a 22% revenue jump to NZ$254.7 million and a 39% increase in operating profit to a record NZ$24.4 million for FY26, exceeding guidance. The company targets over NZ$300 million revenue for FY27, fueled by international expansion and a deepening R&D pipeline.

Invion Limited has partnered with South Korea's SANGMYUNG Innovation to explore its Photosoft™ photodynamic therapy for wet age-related macular degeneration, addressing a large unmet medical need in ophthalmology.

Island Pharmaceuticals has appointed Mark Herzog as Senior Global Health Security Advisor and secured roles in key Medical Countermeasures Coalition groups, boosting its US biodefence engagement ahead of pivotal Galidesivir Animal Rule studies.

Vitasora has launched its proprietary vCare EMR platform, cutting SaaS costs by over 90% and nearly doubling patient enrolments in April. The company targets cashflow breakeven in H2 2026 as enrolment momentum builds.

EBR Systems has landed a significant purchasing agreement with Advocate Health, the third-largest US non-profit health system, opening access for its WiSE wireless cardiac pacing technology across 69 hospitals in eight states.

EBR Systems accelerated its U.S. commercial rollout of the WiSE CRT System in Q1 2026 with implant volumes more than doubling and revenue hitting US$2.4 million. The company also secured a key regulatory milestone in Australia with TGA Priority Review, yet losses deepened and cash burn intensified, raising fresh questions about its funding runway.

EMVision is broadening its emu™ Pivotal Trial to include acute ischaemia detection, aiming to accelerate FDA clearance and enhance the brain scanner's clinical impact. Recruitment has passed 125 patients across US and Australian sites, with full enrolment expected by early 2027.

Neuren Pharmaceuticals saw a 20% jump in Q1 2026 DAYBUE net sales to US$101 million, with royalties up 23%. The Japan trofinetide trial has been fast-tracked, and the new powder formulation DAYBUE STIX gains early traction.