Latest Us Fda News

Neuren Pharmaceuticals reported a 15% rise in 2025 royalties from DAYBUE®, boosted by strong US sales and a new powder formulation launch. The company is progressing its pivotal Phase 3 trial for NNZ-2591 in Phelan-McDermid syndrome and reassessing capital management amid solid cash reserves.

Recce Pharmaceuticals has signed a non-binding term sheet with a major Middle Eastern pharma player for exclusive rights to commercialise its R327 Topical Gel across the MENA region, targeting a high diabetes burden market.

Noxopharm has unveiled new data showing its Sofra technology dramatically boosts TLR8 activation, a key immune pathway, potentially reshaping cancer immunotherapy.

AdAlta has engaged specialist advisors to streamline US FDA regulatory processes for its CAR-T therapy BZDS1901, which has shown rare complete tumour clearance in advanced mesothelioma patients.

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.

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.

Arovella Therapeutics has named Dr Nicole Van Der Weerden as acting CEO following Dr Michael Baker’s departure, positioning her to steer the company through the critical phase I trial of its CAR-iNKT therapy ALA-101.

Noxopharm is gearing up for a pivotal pre-IND meeting with the US FDA, enlisting global CRO Novotech to sharpen its regulatory approach for SOF-SKN, a drug targeting autoimmune skin diseases.

AdAlta has secured A$2.5 million in a strategic placement to push its lead CAR-T therapy BZDS1901 through critical US FDA regulatory steps and establish Australian manufacturing, building on promising clinical responses in advanced mesothelioma.

Imricor Medical Systems has secured A$60 million through a placement to fund its US commercial rollout, regulatory approvals, and clinical programs, boosting its cash reserves to nearly A$103 million.

Clarity Pharmaceuticals’ Phase II Co-PSMA trial confirms its Cu-SAR-bisPSMA PET imaging detects more than twice the prostate cancer lesions versus standard care, driving patient management changes. Phase III AMPLIFY recruitment closes, manufacturing deals inked, and cash sits near $198 million.

Cynata Therapeutics is on the cusp of releasing critical data from its Phase 2 aGvHD and Phase 3 osteoarthritis trials in Q2 2026, while managing a tight cash runway and preparing for a capital raising.