Cell and gene therapy experts question where the FDA designation fits in an environment that features a range of intersecting ...

The hold was placed earlier this year when the FDA asked for more preclinical data, but the agency was slow to respond due to ...

A new group of CDC advisors voted last month to separate the chickenpox vaccine from the measles, mumps, rubella components ...

The centerpiece of the collaboration is the gene editor ABO-101, being developed for primary hyperoxaluria type 1, a rare ...

AstraZeneca has invested heavily in AI, primarily through collaborations, including an up to $5.3 billion partnership with ...

Rocket Pharmaceuticals' strategic realignment initiative in July pulled funding from fanca-cel, which the biotech was ...

This latest FDA program aims to provide speedier reviews for generic drugmakers who produce their products in the U.S.

From Commissioner’s National Priority Vouchers to a push to move away from animal studies to new guidances for oncology and ...

Smarter design through targeted delivery and human-relevant testing can save the industry from costly safety failures.

As industry leaders gather at the annual event in Phoenix, the cell and gene therapy space remains in a state of flux, with M ...

While Bruton’s tyrosine kinase inhibitors are often hailed as the next big breakthrough in multiple sclerosis, Immunic Therapeutics and others are leveraging neuroprotective targets and remyelination ...

Takeda is looking to offload its cell therapy platform and preclinical assets to a yet-unidentified external partner. 137 ...