The FDA  plans to launch generative AI across all of its centers by June 30. The agency has also appointed its first chief AI ...

Dimerix and its kidney drug is on track but with results of its phase III trial not due for years, a few more twists and turns are likely.

The Food and Drug Administration just announced that it will immediately start using AI across all of its centers, after ...

A former critic of FDA and Pharma will now oversee the regulation of costly and complicated biologics like vaccines, gene therapies, and blood supply.

Treatment with the Avmapki Fakzynja Co-pack received accelerated FDA approval for previously treated low-grade serous ovarian ...

Matthew Herper joins Adam and Allison to examine Prasad’s appointment and the band of outsiders now in charge of U.S. health ...

This RMAT designation is based on data from 3 clinical studies demonstrating the potential benefit of AAV-GAD as a one-time treatment for Parkinson's disease - RMAT designation includes the benefits ...

The use of RWD data in place of placebo groups is improving various elements across the clinical trial space.

The FDA has granted accelerated approval to avutometinib (VS-6766) plus defactinib (VS-6063) for the treatment of adult ...

Type C meeting held in May 2025 for DYNE-101 in DM1 and Dyne plans to provide a regulatory update following receipt of meeting minutes - - Registrational Expansion Cohort of ACHIEVE Trial ...

Dyne participated in a Type C meeting with the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) in May 2025 and discussed the path to regulatory approval, ...

The FDA granted regenerative medicine advanced therapy designation to OPGx-LCA5 for the treatment of Leber congenital ...