
FDA Activity Recap: May 2024 Features 2 Expanded Indication Approvals, 2 RMAT Designations, and More
Catch up on any of the key FDA news stories you may have missed last month, with coverage highlights from the CGTLive® team.

Catch up on any of the key FDA news stories you may have missed last month, with coverage highlights from the CGTLive® team.

Sebastien Lefebvre, MSc, the vice president of R&D at Verdot, discussed the company's unique platform.

Candel also recently received orphan drug designation for CAN-3110 for treating recurrent, high-grade glioma.

The Don and Marilyn Anderson Professor of Oncology at University of Wisconsin – Madison shared highlights from the discussion.

Catch up on any of the key data updates you may have missed last month, with coverage highlights from the CGTLive™ team.

The chief product officer at Mission Bio discussed the company’s Genome Editing Solution.

Review top news and interview highlights from the week ending June 7, 2024.

Nine of 14 participants receiving EDIT-101 had meaningful improvements in at least 1 key functional outcome.

ADI-001 is also being evaluated in a phase 1 study in patients with B-cell non-Hodgkin lymphoma.

The professor in the Department of Lymphoma/Myeloma at MD Anderson Cancer Center discussed the advantages the newly approved CAR-T has for older, frailer patients.

The associate professor of clinical pediatrics at Cincinnati Children's discussed further investigations into novel therapies and new research.

Other of the company’s RNAi therapies have recently shown promising data in hyperlipidemia and asthma.

According to recent studies and the latest insights provided by experts, early developments in gene and cell therapies show promise for patients living with Parkinson disease, but challenges remain.

Catch up on the latest news, breakthroughs, and announcements from biotechnology companies making advancements in cell and gene therapies.

The professor of pediatric hematology/oncology at CS Mott Children’s Hospital discussed a sub analysis of the HOPE-B trial.

Nine responses were ongoing as of the March 2023 cutoff date.

The assistant professor at Moffit Cancer Center discussed the subgroup analysis she presented at ASCO’s 2024 Annual Meeting.

GCC19CART targets both guanylate cyclase 2C and CD19.

The Chief Medical Officer of Addimmune discussed the unmet need with HIV and research the company is conducting.

Of 300 screened participants, 68 have been matched by target antigen and HLA expression to a TCR-T in the ImmunoBank.

Patients with large B-cell lymphoma in the TRANSFORM trial showed improvements over 3-year period compared with standard of care.

The associate professor of medicine at University of Colorado discussed updated follow-up data from the phase 3 TRANSFORM trial presented at the 2024 ASCO meeting.

The professor from Cedars Sinai also discussed additional investigations evaluating lifileucel for other advanced subtypes of melanoma.

PFS jumped from under 3 months to over 14 when participants received CB-010 from a donor with at least 4 matched HLA alleles.

The McCaw Endowed Chair of Muscular Dystrophy at University of Washington shared his outlook on the trajectory of research in the field.

The CAR T-cell therapy AIC100 demonstrated promising responses and a low level of toxicity in patients with advanced thyroid cancer.

Carl June, MD, and Michel Sadelain, MD, PhD, were recognized for their pioneering achievements in treating cancer.

Imaging scans also showed disease stabilization, with no new sites of metastatic disease observed.

ACGT Scientific Advisory Council members are pursuing novel research into CAR T-cell therapy for glioblastoma.