Mar 29, 2025 · Out of the total 25 cell and gene therapy products approved between 2020 and 2024, the majority (36%) were approved in 2024, highlighting a substantial acceleration in …

Dates included in this email are reflective of likely FDA approval date (otherwise known as PDUFA date). Actual approval date may occur before or after the date shown.

Jul 1, 2025 · 2024, ushered in by the FDA approval of the first treatments using the Nobel Prize-winning CRISPR gene-editing system, got off to a ground-breaking start for cell and gene …

Oct 16, 2025 · In terms of product mix, of the 33 new molecular entities and biological therapeutics approved by FDA’s CDER thus far in 2025 (as of mid October 2025), small …

As of early 2025, the FDA has approved over 30 cell and gene therapies, and industry experts anticipate 30-50 additional cell and gene therapy approvals by 2030.

Nov 25, 2024 · While 2023 was heralded as a breakthrough year for cell and gene therapy with the U.S. FDA greenlighting seven new treatments, 2024 is keeping pace. The tally currently …

Feb 28, 2025 · In this article, we recap the significant FDA regulatory considerations for CGTs in 2024 and offer a preview of potential developments for 2025.

Dec 30, 2024 · An analysis of FDA approvals across these five years shows small molecules remain central to modern therapeutics, even as complex biologics—particularly monoclonal …

May 6, 2024 · Here we take a glance at the recent advancements in therapy approvals and clinical developments across various disease areas, highlighting recent advancements in …

Dec 4, 2024 · Cell and gene therapies (CGTs) show promise as curative treatments for various diseases that currently have few existing treatment options. 1 In 2017, the Food and Drug …