Latest Fda News

Actinogen Medical has obtained positive scientific advice from the European Medicines Agency that aligns with prior FDA guidance, clarifying regulatory requirements for its Alzheimer’s drug Xanamem and paving the way for a streamlined approval process in major markets.

Nexalis Therapeutics has locked in a $53 million non-dilutive funding facility with Point8 Capital, replacing its previous lender and supporting three clinical programs targeting breakthrough cancer pain, panic disorder, and treatment-resistant depression.

Tetratherix Limited secures $15 million via institutional placement plus a capped $2 million share purchase plan at a 14% discount, aiming to fast-track manufacturing expansion and commercial partnerships.

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.

EMVision's First Responder Brain Scanner has proven its operational feasibility in aeromedical settings with the Royal Flying Doctor Service, de-risking rural stroke diagnosis and supporting progression to commercial production.

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.

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

Anteris Technologies Global Corp. has initiated an at-the-market equity offering to raise up to US$250 million, aiming to accelerate development of its DurAVR transcatheter heart valve and support general corporate needs.

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.

PainChek has secured A$5.5 million via convertible notes to accelerate its US sales expansion and strengthen working capital amid key commercial milestones.

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.