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February 02, 2024
The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.
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 25, 2024
The 2024 Pharmapack Europe Award winners include companies involved in ground-breaking innovations in novel drug delivery solutions, reusable connected devices, and recyclable packaging.
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.
January 17, 2024
The agency is reviewing data on secondary malignancies related to T-cells for approved CAR T-cell medicines.
January 15, 2024
The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate.
January 11, 2024
Regulators from around the world will gather to help shape the mRNA and RNA therapeutics landscape at an exceptional April 2024 Washington, D.C. convocation.
December 29, 2023
Clinician-Scientists are vital innovation spark plugs, accounting for 40% of Nobel awards in Physiology or Medicine, and two thirds of Big Pharma CSOs.