Tag: novel

– If approved, nirogacestat will be the first and only therapy with marketing authorization in the EU for the treatment of desmoid tumors –

PARIS, FRANCE, 20 June 2025 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Cabometyx® (cabozantinib) for adult patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumors who have progressed following at least one prior systemic therapy other than somatostatin analogues. This recommendation is based on results from the CABINET Phase III trial presented at the European Society of Medical Oncology (ESMO) Congress 2024 and published in the New England Journal of Medicine.^3,4 A final decision on the approval in the European Union is expected in the coming months.

TORONTO and HAIFA, Israel, June 20, 2025 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (OTCQB: NRXBF) (FSE: J90) (“NurExone” or the “Company”), a biotech company developing exosome-based therapies for central nervous system injuries, announced today that it has been accepted into the HealthTech Hub (“HTH”) Accelerator Program. Based in Boston, Massachusetts, home to more than 1,000 biotech companies¹, HTH is operated by the Advanced Regenerative Manufacturing Institute (“ARMI”) and its BioFabUSA initiative.

Approval based on pivotal results showing improvements in sustained disease remission and reductions in itch and oral corticosteroid use compared to placebo in adults with BP