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The U.S. Food and Drug Administration (FDA) is alerting patients and health care providers about the voluntary withdrawal of Tazverik (tazemetostat) tablets from the market due to an increased rate of hematologic second primary malignancies (SPMs) — the development of new blood cancers in people treated with Tazverik for a different cancer. As a result, …

FDA Alerts Health Care Providers and Patients about Increased Risk of New Blood Cancers with Tazverik (tazemetostat) Use; Sponsor to Voluntarily Withdraw Product from Market Read More »

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.

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 The document finalizes the draft guidance that was issued on October 28, 2022.

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.

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.