With CAR-T approval, FDA steps up efforts at regulating stem cell clinics

About two months and two weeks after the FDA’s advisory committe recommended for approval Novartis’ CAR-T therapy for the treatment of  relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL), the FDA followed up with an official approval. Tisagenlecleucel – or, as the therapy is commonly known, Kymriah – will head

FDA Introduces ‘Regenerative Medicine Advanced Therapy’ Drug Designation

At the end of 2016, the United States Congress passed the 21st Century Cures Act. Addressing some of the provisions included in the Act, the FDA followed through, on January 17, 2017, by introducing a new designation process for regenerative advanced therapies, called Regenerative Medicine Advanced Therapies (RMAT). On a fundamental level, this new designation provides an