HEALTHSTORY 532· JUNE 30, 2026

FDA's Top Gene Therapy Regulator Vijay Kumar Steps Down Amid Continuing CBER Turnover

Vijay Kumar, the acting director of the Food and Drug Administration's Office of Therapeutic Products — the unit that reviews cell and gene therapies for safety and approval — is leaving his post, according to an internal email obtained by…

NDNewsDialy Desk2 MIN READ

SOURCE

statnews.com

← PREVIOUS STORY 531PrimeStone Capital Presses Gresham House Energy Storage Fund Board to Launch Sale Process NEXT STORY 533 →Ping An Climbs to No. 26 on Forbes Global 2000, Ranks Second Among World's Insurers

Keep reading

More from the desk.

12HEALTH

FDA clears Replimune's melanoma drug Tudriqev after two rejections

A cancer treatment rejected twice by federal regulators has now won approval. The Food and Drug Administration granted accelerated approval to Tudriqev, a drug made by the biotech company Replimune, for patients with advanced melanoma…

health2 MIN

50HEALTH

Seven months after launch, Aurora Therapeutics scraps its lead gene-editing program and cuts staff

Personalized CRISPR therapies, gene-editing treatments built around one patient's specific mutation rather than a disease shared by millions, just lost one of their early backers. Aurora Therapeutics has scrapped its lead program and laid…

health2 MIN

65HEALTH

California Supreme Court rules Gilead Sciences has no legal duty to fast-track a safer HIV drug

Pharmaceutical companies do not owe patients a legal duty to speed up development of a safer drug simply because a less safe version is already on the market. That concept, called a "duty to innovate," was at the center of a case brought…

health2 MIN

Tomorrow · 06:00

Start tomorrow already ahead.

Five stories, a two-minute read, zero noise — the world before your first coffee.

Get the 6AM brief Back to the desk