The reported dismissal of high-ranking CBER officials Nicole Verdun and Rachael Anatol resurfaced lingering concerns about how gene therapies will be regulated under new FDA leadership.

The next-gen platform is set to accelerate precision medicine with realistic disease modeling and faster results.

Shares of gene editing companies were largely steady in the premarket on Friday after the FDA’s Center for Biologics Research ...

Bengaluru: The U.S. Food and Drug Administration (USFDA) top vaccine official, Vinay Prasad, has been appointed as the agency ...

By helping clients address challenges that may arise during the drug discovery phase, Samsung Biologics aims to enhance clinical success rates. "The latest service launch reflects our unwavering ...

Vinay Prasad, the FDA’s freshly appointed head of vaccines, has been named chief medical and scientific officer, taking on ...

FDA Commissioner Martin Makary, MD, shared his vision for a “New FDA” with biopharma leaders attending BIO in Boston.

SEOUL, June 19 (Yonhap) -- Lotte Biologics Co., the biotech arm of Lotte Group, said Thursday it has signed a contract with ...

The latest shake-up at the FDA forced out the top two officials in charge of reviewing cell and gene therapies, analysts said.

The ouster of the FDA's chief regulator of cell and gene therapies came immediately after a disagreement with her boss over a ...

Samsung Biologics launches drug screening services, Samsung Organoids: Incheon, S. Korea Tuesday, June 17, 2025, 12:00 Hrs [IST] Samsung Biologics, a leading contract development ...

The US FDA has approved Ocugen’s IND amendment to commence a Phase II/III pivotal confirmatory study of OCU410ST.