EU recommendations for 2026/2027 seasonal flu vaccine composition
EMA has issued recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2026.
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FDA Issues Final Guidance on Developing Drugs for Clostridioides difficile Infection (CDI)
The Food and Drug Administration (FDA) has announced the availability of the final guidance, Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, or Prevention. This guidance is designed to assist drug sponsors in the clinical development process for medications intended to treat, reduce recurrence of, or prevent Clostridioides difficile infection (CDI). The document finalizes the draft guidance that was issued on October 28, 2022.
FDA approves zenocutuzumab-zbco for advanced, unresectable or metastatic cholangiocarcinoma
On May 8, 2026, the Food and Drug Administration approved zenocutuzumab-zbco (Bizengri, Partner Therapeutics, Inc.) for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. NRG1-fusion positive cholangiocarcinoma is an extremely rare, life-threatening malignancy.
FDA Releases Version 4.1 of OND Custom Medical Queries
The U.S. Food and Drug Administration’s (FDA) Office of New Drugs (OND) has released version 4.1 of the OND Custom Medical Queries (OCMQs), which includes terms released in MedDRA v27.0 and earlier.