Latest Fda News

Island Pharmaceuticals has appointed Raymond Taylor, a former BioCryst executive with deep Galidesivir expertise and US government funding experience, to accelerate development and procurement efforts for its broad-spectrum antiviral amid rising viral threats.

Argenica Therapeutics has passed a critical FDA genotoxicity test for its stroke drug ARG-007, advancing its IND application and edging closer to Phase 2b clinical trials in the US and Australia.

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.

Patrys has appointed CMAX and Alithia Life Sciences to lead its Phase 1A clinical trial operations for RLS-2202, advancing its injectable quetiapine program toward first-in-human testing in Q3 2026, pending ethics approval.

Cleo Diagnostics has laid out a clear U.S. reimbursement pathway for its ovarian cancer test, leveraging an existing CPT code to enable early market entry and data collection ahead of FDA clearance.

Alterity Therapeutics has showcased compelling Phase 2 data for ATH434 in Multiple System Atrophy, paving the way for a Phase 3 trial with FDA engagement targeted for mid-2026.

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.

Amplia Therapeutics has launched a Phase 2b trial testing a new daily dosing regimen of narmafotinib combined with chemotherapy in advanced pancreatic cancer, aiming to accelerate progress towards a pivotal Phase 3 study.

Lumos Diagnostics advances US commercial rollout of FebriDx with positive reimbursement data and expanded urgent care adoption ahead of the 2027/28 flu season.

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.