Latest Us Fda News

AdAlta has completed a key US$1 million milestone payment securing rights to its lead CAR-T therapy EW-001 outside Greater China, progressed Australian manufacturing with first runs expected late 2026, and is preparing for a critical pre-IND meeting with the US FDA.

NeuroScientific Biopharmaceuticals achieved an 80% clinical response rate in fistulising Crohn’s disease patients treated under the TGA Special Access Scheme, advancing plans for Phase 2 trials and manufacturing scale-up.

Clinuvel Pharmaceuticals targets year-end for topline results from its pivotal vitiligo trial of SCENESSE® combined with narrowband UVB, aiming to expand the drug's use beyond its current rare disease indication.

Syntara secured positive FDA feedback for its Phase 2b amsulostat trial in myelofibrosis and raised $8 million to extend its cash runway to Q3 2027, while preliminary data showed promising brain inflammation reduction in a Parkinson’s-related disorder.

Imricor Medical Systems has officially launched its US commercial operations, securing Rady Children’s Hospital–San Diego as the first customer for its NorthStar iMR mapping system, following key FDA clearances including pediatric approvals.

Argenica Therapeutics is gearing up for a pivotal late-stage clinical trial of its neuroprotective drug ARG-007 (xaranetide) in acute ischaemic stroke, backed by strong safety assays and solid funding.

Noxopharm reported significant progress in its Sofra technology, highlighting enhanced cancer drug potential and preparations for a US FDA clinical trial, while managing tight cash reserves.

Ceretas Limited is raising $8 million through an IPO to fund clinical trials and development of its novel therapeutic ultrasound device targeting Alzheimer’s disease symptoms.

Recce Pharmaceuticals secured a non-binding term sheet with a major Middle Eastern pharma for its diabetic foot infection treatment and raised A$4 million to fund pivotal Phase 3 trials in Australia and Indonesia.

AFT Pharmaceuticals has received tentative US FDA approval for its Scomara cream to treat Facial Angiofibromas in Tuberous Sclerosis, but US commercialisation is postponed until 2029 due to orphan drug exclusivity. The approval bolsters regulatory prospects in other key markets where AFT anticipates competitive advantages.

AFT Pharmaceuticals secures tentative FDA approval for Scomara cream to treat rare facial tumours but faces a US launch delay due to orphan drug exclusivity. The approval bolsters prospects in other markets where AFT expects competitive advantages.

Optiscan Imaging has fast-tracked Stage 2 of its pioneering head and neck cancer imaging study, moving into live intraoperative imaging ahead of schedule. This advancement supports FDA regulatory efforts and enhances the company’s AI imaging development.