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EMA’s Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant XFG for the 2026/2027 vaccination campaign. XFG is part of the JN.1 family of Omicron subvariants. Its circulation has increased worldwide since June 2025, peaking at 74% of infections genetically sequenced globally in October 2025, and it still remains prevalent among …

ETF recommends updating COVID-19 vaccines to target XFG variant Read More »

The U.S. Food and Drug Administration (FDA) published a final guidance for industry, “Pulmonary Tuberculosis:  Developing Drugs for Treatment,” last month. The guidance aims to assist sponsors in the clinical development of investigational drugs to treat pulmonary tuberculosis (TB), an airborne bacterial infection caused by Mycobacterium tuberculosis (M. tuberculosis) that primarily attacks the lungs.

The guidance for industry entitled “Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA” provides recommendations to applicants planning abbreviated new drug application (ANDA) submissions on how to meet the bioequivalence (BE) requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations. The guidance for industry entitled …

FDA publishes two final guidances for industry: “Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA” and “Statistical Approaches to Establishing Bioequivalence” Read More »

On May 28, 2026, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).

On May 27, 2026, the Food and Drug Administration approved pivekimab sunirine-pvzy (Decnupaz, AbbVie, Inc.), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).