FDA Approval Process - Search News

FDA, Hard-To-Treat Diseases

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

Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to-treat diseases, including for rare genetic conditions that the pharmaceuti...

The American Journal of Managed Care · 5d

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

· 12h

New FDA Proposal Aims To Help Patients With Hard-To-Treat Diseases

· 16h

Gene editing takes centre stage in FDA’s new rare disease approval pathway

The US Food and Drug Administration (FDA) has issued more information to sponsors regarding its “plausible mechanism pathway”, a new framework to spur the development of therapies for ultra-rare disea...

Becker's Hospital Review · 1d

FDA unveils pathway for ultra-rare disease therapies

· 1d

FDA fleshes out new roadmap for testing personalized therapies

Fierce Biotech

FDA illuminates new approval pathway for bespoke gene editing therapies

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, like the one that treated critically ill baby KJ last year, formally embraced by the agency.

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 https://www.usnews.com/news/business/articles/2026-02-18/fda-will-drop-two-study-requirement-for-new-drug-approvals-aiming-to-speed-access