Pharmaceutical Technology

FEBRUARY 3, 2023

With scientists fervently developing mRNA vaccines, nucleic acid therapeutics, and viral vector-based gene therapies, clinicians are set to have a growing number of tools available to treat a wide range of conditions, from infectious diseases to genetic disorders and more. Biores Open Access. 2020 Oct 16;9(1):219-228. doi: 10.1089/biores.2020.0031.

Genome 244

Genome Genomics Medicine Gene Therapy 244

FDA Law Blog

MAY 19, 2023

The submission will need to include a “detailed description of a protocol for continuous monitoring, identification, and handling of genetic mutations and/or novel isolates or strains.” Continuous Monitoring and Post Market Reporting Special Controls Within the Special Control for Risk Analysis are details regarding continuous monitoring.

Reagent 40

Reagent Genetics Contamination Marketing 40

XTalks

JANUARY 6, 2025

Furthermore, CRISPR/Cas9 presents a promising avenue for overcoming genetic diseases in the near future. CAR-T cell therapies continue to dominate the pipeline for genetically modified cell therapies, with 97 percent of them targeting cancer. By 2025 , 10 to 20 new gene therapies are expected to gain approval each year.

Gene Therapy 111

Gene Therapy RNA Gene Editing Gene 111