OR WAIT null SECS
February 04, 2024
NICE has recommended the use of AbbVie's Tepkinly as a treatment option for eligible adults with diffuse large B-cell lymphoma.
February 02, 2024
In the ATMP space, CGTs are hitting their stride with unprecedented approvals in the past year alone.
The milestone approval of a gene-edited therapeutic paves the way for gene-editing technologies.
February 01, 2024
The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.
January 31, 2024
The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.
January 24, 2024
Takeda has received FDA approval for HYQVIA, a subcutaneous immunoglobulin for the maintenance treatment of chronic inflammatory demyelinating polyneuropathy.
January 19, 2024
The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.
January 18, 2024
FDA’s Center for Drug Evaluation and Research released its report on new drugs approved in 2023.
December 21, 2023
The final guidance document provides recommendations for designing a new registry or using an existing registry to support decisions regarding safety and effectiveness of a drug.
December 14, 2023
RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.