Tag: quality

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

MIAMI, June 20, 2025 (GLOBE NEWSWIRE) -- AYR Wellness Inc. (CSE: AYR.A, OTCQX: AYRWF) (“AYR” or the “Company”), a leading vertically integrated U.S. multi-state cannabis operator, announces that it has entered into an amendment (the “Extended Agreement”) to the previously disclosed Limited Waiver Agreement dated June 6, 2025 (the “Original Agreement”). The Extended Agreement formally extends the temporary waiver period set forth in the Original Agreement from June 19, 2025, to July 3, 2025.‎

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.