PharmExec

FDA Removes Two Study Requirement for New Drug Approval Process: Report

FDA Will Drop Two-Study Requirement for New Drug Approvals, Aiming to Speed Access U.S News February 18, 2026 ...
Healio

FDA takes steps to reduce animal testing requirements for monoclonal antibodies

Please provide your email address to receive an email when new articles are posted on . The FDA plans to reduce and potentially replace animal testing for developing monoclonal antibody therapies and ...
FierceBiotech

FDA plans to end animal testing requirements for monoclonal antibody drugs

The FDA is moving away from requiring animal models for investigational new drug (IND) applications for new monoclonal antibodies and some other drug candidates. Animal testing will be "reduced, ...
KJCT8

FDA to phase out animal testing requirements

(CNN) - The Food and Drug Administration said it will phase out a requirement that certain drugs and monoclonal antibodies be tested on animals. In a statement, the FDA said it’s taking this step ...

FDA will drop two-study requirement for new drug approvals, aiming to speed access

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals ...