Regulatory News
Navigating the evolving landscape of drug development and regulatory compliance can be complex and challenging. From FDA guidance updates to international regulatory changes, staying informed is critical for researchers, biotech innovators, and pharmaceutical professionals. This page brings you a curated list of the most important news in drug development regulation, highlighting updates from the FDA, EMA, and other regulatory bodies around the world
Regulatory News
Navigating the evolving landscape of drug development and regulatory compliance can be complex and challenging. From FDA guidance updates to international regulatory changes, staying informed is critical for researchers, biotech innovators, and pharmaceutical professionals. This page brings you a curated list of the most important news in drug development regulation, highlighting updates from the FDA, EMA, and other regulatory bodies around the world.
The U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of type 1 diabetes. Lantidra is approved for the treatment of adults with type 1 diabetes who are unable to approach target glycated hemoglobin (average blood glucose levels) because of current...
The goal of the hypoimmune platform is to overcome the immunologic rejection of allogeneic cells, which if true for SC291 may result in longer CAR T cell persistence and a higher rate of durable complete responses for patients with B-cell lymphomas or leukemias. The hypoimmune platform includes disruption of major...
ASGCT held its fifth annual liaison meeting with FDA CBER’s Office of Tissues and Advanced Therapies (OTAT) on Nov. 14, 2022. A group of Society leaders and members gave two presentations to FDA on significant topics in the field, followed by a presentation from FDA. Dr. Keith Wonnacott, ASGCT’s Regulatory Affairs Committee Chair, chaired the meeting and moderated discussion...
Company files its first Investigational New Drug application for its lead program KYV-101, a novel fully human CD19 CAR T-cell therapy, for the treatment of lupus nephritis. Kyverna’s therapeutic platform combines advanced T-cell engineering and synthetic biology technologies to suppress and eliminate...
Century Therapeutics, an innovative biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies in immuno-oncology, announced today that the company has been notified by the U.S. Food and Drug [...]
bluebird bio has announced the the U.S. Food and Drug Administration (FDA) has approved ZYNTEGLO® (betibeglogene autotemcel), also known as beti-cel, a one-time gene therapy custom-designed to treat the underlying [...]
On March 15th, 2022 the FDA is announcing the availability of two draft guidance documents: “Human Gene Therapy Products Incorporating Human Genome Editing,” and “Considerations for the Development of [...]
Graphite Bio is a clinical-stage, next-generation gene editing company harnessing the power of high-efficiency precision gene repair to develop therapies with the potential to treat or cure serious diseases. [...]
The Center for Biologics Evaluation and Research (CBER) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. CBER uses both the [...]
Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology to identify patients with specific types of mutations [...]