Tag: Regulatory

FORM 8.5 (EPT/RI)

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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

Abivax Announces Full Exercise of Underwriters’ Option to Purchase Additional ADSs, Bringing Gross Proceeds of Offering to $747.5M (€637.5M)

Schlieren / Zurich, Switzerland, 25 July, 2025 – Memo Therapeutics AG ("MTx”), a late-stage biotech company translating unique immune responses into superior medicines to treat viral infections and cancer, today announced results from its Phase II clinical trial evaluating potravitug, a highly potent human BK polyomavirus (“BKPyV”)-neutralizing monoclonal antibody, for the treatment of BKPyV infection in kidney transplant recipients (“KTR”).

NEW YORK, July 24, 2025 (GLOBE NEWSWIRE) --

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Biohaven Ltd. (NYSE: BHVN) between March 24, 2023 and May 14, 2025, both dates inclusive (the “Class Period”), of the important September 12, 2025 lead plaintiff deadline.