Industry

Advanced Therapies

Cell and gene therapies, oncolytic viruses included: approvals, advisory committees, review extensions and sponsor guidance.

8 stories

All coverage

8 stories, newest first.

Search within Advanced Therapies coverage, or narrow it further.

Sections Agencies Series

Showing 8 of 8 stories

A researcher wearing safety glasses and a white lab coat looks through a microscope eyepiece while adjusting a sample slide

Drugs & Biologics FDA Approves First Gene Therapy for Sanfilippo Type A Sep 18, 20265 min read Read the story

Two masked lab researchers review notes on a clipboard while operating a microscope, surrounded by lab glassware

Drugs & Biologics FDA Extends Review of Capricor's Duchenne Therapy Aug 24, 20265 min read Read the story

A senior scientist in a cleanroom gown and hairnet adjusts a microscope while a gowned colleague assists at the bench

Guidance & Policy FDA Finalizes FAQ Guide for Cell, Gene Therapies Aug 23, 20266 min read Read the story

The U.S. Supreme Court Building in Washington, D.C., framed by blooming cherry trees under a clear blue sky

Drugs & Biologics FDA Approves First Gene Therapy for GSDIa Aug 20, 20266 min read Read the story

A scientist in a white lab coat and safety glasses reviews handwritten notes on a clipboard in a laboratory corridor, with a colleague behind her

Drugs & Biologics FDA Approves Replimune's Twice-Rejected Melanoma Drug Aug 6, 20266 min read Read the story

Two researchers in a laboratory, one examining a sample under a microscope while a colleague works at a fume hood in the background

Drugs & Biologics FDA Panel Votes 9-3 Against Capricor's DMD Heart Drug Aug 2, 20266 min read Read the story

A researcher wearing glasses looks through a binocular microscope while a colleague in a lab coat stands in the background

Drugs & Biologics FDA's Cell Therapy Panel Revisits a Once-Rejected DMD Drug Jul 26, 20266 min read Read the story

A scientist at FDA's Center for Biologics Evaluation and Research examining a cell-culture flask under an inverted microscope

Drugs & Biologics FDA Sets a July 30 Panel on Replimune's Melanoma Drug Jul 17, 20265 min read Read the story