The FDA has offered positive feedback on possible paths forward for accelerated or traditional approval of FLT201 using data from a single-arm study.

The international formula was designed to deliver all the benefits of the US formula while meeting regulatory requirements ...

For the last 10 years, the only effective treatment for hypophosphatasia (HPP) has been an enzyme replacement therapy that ...

Announcing a new article publication for BIO Integration journal. As altitude increases, the partial pressure of oxygen will ...

Stanford researchers introduced affordable gene-editing kits ready for the classroom, aiming to make the field more accessible for high school students.

Researchers discovered that ALPK2, a heart-specific enzyme, may protect against HFpEF by activating TPM1 in heart muscle ...

A team of biomolecular engineers, pathologists, and internal medicine specialists at the University of Texas Medical Branch, ...

By creating gene editors not found in nature, or optimizing existing editors, AI can improve the accuracy, effectiveness, and accessibility of gene editing.

Several companies—including JCR Pharmaceuticals, Denali Therapeutics and Regenxbio— have products in the pipeline that could ...

NGS revenue guidance was raised to $205 million to $209 million, reflecting 21%-24% growth. Biopharma revenue was guided to $23 million for fiscal 2025, representing 13% year-over-year growth.

FDA aligned on single-arm Phase 3 study to support potential accelerated and full approvalOn track to dose first patient in Phase 3 trial in ...