"Regulatory flexibility must be tailored for cell and gene therapies," commented FDA Commissioner Marty Makary. "These are ...

“Regulatory flexibility must be tailored for cell and gene therapies,” said FDA Commissioner Marty Makary, M.D., M.P.H. “These are common-sense reforms that will address the unique characteristics of ...

Akadeum Life Sciences, the leader in buoyant microbubble cell separation, today announced that its Chief Executive Officer Brandon McNaughton, PhD, will present at Biotech Showcase (TM) 2026 in San ...

Atara Biotherapeutics, Inc. , a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer ...

Global Life Science Consulting Services Market OverviewThe global life science consulting services market is projected to ...

The firm expects its $1.25 billion cash runway to cover operating and capital expenses through 2029, including development plans for key assets.

Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.

The FDA has updated guidance outlining how it applies regulatory flexibility to chemistry, manufacturing and control requirements for cell and gene therapies. The agency said the approach is meant to ...

GEN’s first virtual event of 2026—we present a group of outstanding researchers and thought-leaders to discuss the latest advances and challenges in delivering genetic therapies.

The pharmaceutical industry is calling on the FDA to modernise how it tracks the long-term safety and efficacy of cell and ...

Ultragenyx Pharmaceutical (RARE) has completed the rolling submission of its U.S. marketing application for its gene therapy candidate DTX401 for a rare disorder called Glycogen Storage Disease Type ...

The FDA on Tuesday approved etuvetidigene autotemcel (Waskyra) as the first cell-based gene therapy for patients 6 months and older with Wiskott-Aldrich syndrome, a rare primary immunodeficiency. The ...