The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...
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 ...
One week after releasing its 11-part biosimilar action plan, the US Food and Drug Administration (FDA) announced it will hold a public hearing to gather input on how it can facilitate the development ...
Cathy Burgess, Yifan Wang, Ph.D. Our FDA: Drug & Device Team explores the Food and Drug Administration’s updated draft guidance that eases biosimilar development by allowing greater use of ...
The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...
SUNNYVALE, Calif.--(BUSINESS WIRE)--JSR Life Sciences, LLC (JSR) today announced the launch of a new business division, Similis Bio (Similis), which will operate a partnering program designed to help ...
Each major element of the new guidance corresponds to a reform Professor Niazi advocated in peer-reviewed literature and formal citizen petitions to the FDA: Niazi published a critical analysis ...
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