EMA welcomes the provisional agreement reached by the European Parliament and the Council of the European Union on the proposed Critical Medicines Act (CMA), which represents an important step in strengthening the resilience, security and sustainability of the European Union’s supply of critical medicines.
EMA is actively monitoring the ongoing hantavirus outbreak linked to a cruise ship, in coordination with other EU bodies. The virus has been identified as Andes hantavirus, the only hantavirus that can be transmitted person-to-person, typically requiring close, prolonged contact. Based on the available evidence so far, the European Centre for Disease Prevention and Control (ECDC) …
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On May 13, 2026, the Food and Drug Administration approved an oral combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology, Inc.) with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.
On May 13, 2026, the Food and Drug Administration granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines USA, Inc.), a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
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, …
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 The document finalizes the draft guidance that was issued on October 28, 2022.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.
