Tag: trial

Bergen, Norway, July 23, 2025 – Cytovation ASA, a clinical stage oncology company focused on the development of its first-in-class bifunctional peptide CY-101, announces that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO-INN) has approved "getacatetide" as the International Nonproprietary Name (INN) of CY-101.

PARIS, FRANCE, 23 July 2025 - Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty care biopharmaceutical company, today announced the following changes to its Executive Committee:

Largest commercial insurer in the United States releases positive comprehensive coverage for AI-enabled Heartflow Plaque Analysis to support precise diagnosis and management of patients

^{*Non-GAAP - refer to the section titled Non-GAAP Financial Measures Defined and GAAP to Non-GAAP Financial Measures Reconciled}

ATLANTA, July 22, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Replimune Group, Inc. (“Replimune” or the “Company”) (NASDAQ: REPL) complied with federal securities laws. On July 22, 2025, Replimune announced it received a Complete Response Letter (“CRL”) from the FDA regarding the Biologics License Application (“BLA”) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. In the CRL, the FDA indicated “that the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.” Following this news, the price of the Company’s stock dropped.