Healio

FDA provides new approval process for rare disease therapies without large clinical trials

The FDA has introduced a new approval process for targeted individualized therapies, including genome editing and RNA-based ...

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 ...
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 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 ...
WLKY

FDA to streamline approvals for generic biological drugs in latest move targeting health costs

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...
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teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...
MobiHealthNews

FDA approval process too slow for wireless health

"With the FDA recently saying too many [medical] devices are getting approved too easily and some other things they are articulating, it's frustrating," Montage Systems CEO Eric Collins said during a ...