The U.S. Food and Drug Administration (FDA) has issued new draft guidance modernizing statistical methodologies used in ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

2024 saw the highest number of biosimilars approved by the US Food and Drug Administration (FDA) in a calendar year, with this year set to break this record again, analysis suggests. The FDA approved ...

Denosumab is a monoclonal antibody that inhibits bone resorption and is widely used across oncology and osteoporosis-related ...

Please provide your email address to receive an email when new articles are posted on . Nufymco is indicated for the treatment of patients with a number of retinal diseases. The VEGF inhibitor is the ...

On Wednesday, Oct. 29, the Food and Drug Administration (FDA) issued draft guidance proposing to update its biosimilar review framework. Under the new approach, most biosimilar applications will no ...

The FDA recently gave his company a waiver from conducting a costly clinical trial of its biosimilar substitute for Keytruda, a blockbuster cancer drug. But Merck & Co., which got about half of its ...

Michael Ellenberger, Aydin Harston Ph.D. On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for ...

The FDA has approved Poherdy (pertuzumab-dpzb), the first interchangeable biosimilar to Perjeta (pertuzumab). Poherdy, as approved, is indicated for use in adults with HER2-positive breast cancer, ...

Samsung Epis Holdings, the new holding company for Samsung Bioepis, is pursuing a bold expansion strategy focused on pipeline ...