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 ...

FDA proposes new system for approving customized drugs and therapies for rare diseases

The FDA guidelines aim to create a new pathway for bespoke therapies due to the challenges of conducting large studies.
Pharmaceutical Commerce

FDA Shifts Toward Single Trial Requirement for New Drug Approvals

A policy change allowing approval of some new drugs based on one adequate and well-controlled study could accelerate ...

FDA unveils proposal for streamlined approval of customized drugs for rare diseases

The FDA has proposed new guidelines to expedite the approval of customized treatments for rare diseases, creating a ...
Yahoo Finance

2 Day Virtual FDA (Food and Drug Administration) Drug Approval Process Training Course (Feb ...

Dublin, Dec. 12, 2025 (GLOBE NEWSWIRE) -- The "The FDA (Food and Drug Administration) Drug Approval Process Training Course (Feb 23rd - Feb 24th, 2026)" training has been added to ...

FDA unveils new pathway for approving customized treatments for rare diseases

The FDA has proposed new guidelines to facilitate the approval of customized treatments for rare diseases, aiming to address ...