Tag: biologics

NEW YORK and MAINZ, GERMANY, July 25, 2025 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY^® LP.8.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the EMA’s Emergency Task Force (ETF) to update COVID-19 vaccines to target the LP.8.1 variant for the 2025-2026 season. The ETF stated that “targeting LP.8.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve.”²

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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. 

MELBOURNE, Australia and INDIANAPOLIS, July 22, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today provides an update on its commercial and operational performance for the quarter ended 30 June 2025 (Q2 2025). All figures are in USD unless stated otherwise.