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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).

EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Vijoice to treat adults and children aged 2 years and older with severe or life-threatening PIK3CA-related overgrowth spectrum (PROS) disorders.

EMA has recommended an extension to the marketing authorisation for Wegovy (semaglutide) in the EU to add an oral formulation for weight management. Wegovy tablets can be used, together with diet and physical activity, in adults with obesity, or in those who are overweight and have at least one weight-related comorbidity. This is the first glucagon-like peptide …

EMA: First oral GLP-1 treatment for weight management Read More »

EMA has recommended granting a marketing authorisation in the European Union (EU) for Jascayd (nerandomilast) to treat adults with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF), two serious lung diseases that involve progressive and irreversible scarring (fibrosis) of the lung tissue.

On May 22, 2026, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.