Latest Us Fda News

Nyrada has secured ethics approval to start its Phase IIa trial of Xolatryp in heart attack patients, with recruitment beginning in April 2026. The biotech also bolsters its cash position to AU$6.74 million and pursues new oncology indications.

Racura Oncology has enrolled the first patient in its Phase 1 HARNESS-1 trial, testing RC220 alongside osimertinib to tackle resistance in EGFR-mutant non-small cell lung cancer. This milestone sets the stage for a multi-centre study aiming to improve treatment outcomes.

Cynata Therapeutics has completed the 100-day primary evaluation period for its Phase 2 trial of CYP-001 in acute graft versus host disease, with results expected in June 2026. This milestone marks a critical step for the biotech’s lead cell therapy candidate in a condition with few effective treatments.

Lumos Diagnostics has secured a pivotal US FDA CLIA waiver for its FebriDx® test, vastly expanding its market reach and triggering milestone payments that bolster its US commercial rollout.

AdAlta’s subsidiary AdCella has completed its first Joint Development Committee meeting with Shanghai Cell Therapy Group, advancing the development of the CAR-T therapy BZDS1901 with potential timeline acceleration and reduced regulatory risks.

Recce Pharmaceuticals is progressing its Phase 3 clinical trial of RECCE 327, a novel synthetic antibiotic targeting multidrug-resistant infections, with interim data from Indonesia supporting registration plans across ASEAN by 2026.

Percheron Therapeutics reports a 64% reduction in half-year losses to $3.1 million, driven by progress in its licensed immuno-oncology drug HMBD-002 and a strategic pivot away from discontinued assets.

Prescient Therapeutics reported a 62.8% increase in half-year losses to nearly $4 million, driven by intensified clinical development of its PTX-100 cancer therapy. The company bolstered its balance sheet with a $9.85 million capital raise while securing key regulatory milestones in Europe and the US.

Neurotech International has reported positive long-term safety results for its lead drug candidate NTI164, bolstering its path towards regulatory approval and chronic use in paediatric neurological disorders.

Clarity Pharmaceuticals reports another metastatic prostate cancer patient achieving undetectable disease markers in its Phase II SECuRE trial, reinforcing promising efficacy and safety of its Cu-SAR-bisPSMA radiopharmaceutical.

AdAlta Limited reported a $2.44 million loss for H1 FY26 while progressing a key CAR-T therapy collaboration and raising $2.8 million in capital. The company’s ‘East to West’ immunotherapy strategy gains momentum with regulatory tailwinds and cost efficiencies.

Clarity Pharmaceuticals’ Cu-64 SAR-bisPSMA diagnostic agent significantly outperformed the current standard Ga-68 PSMA-11 in detecting prostate cancer recurrence, more than doubling lesion and patient detection rates in a pivotal head-to-head trial.