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March 15, 2024
The draft guidance document provides support to sponsors with drugs in clinical development that treat the states of sporadic Alzheimer’s disease.
February 21, 2024
FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.
February 20, 2024
FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.
February 16, 2024
Two public electronic catalogues will be available for real-world data sources and for real-world data studies.
February 12, 2024
The agency’s safety committee stressed the risk of potential adverse reactions involved with taking Paxlovid (nirmatrelvir, ritonavir) in combination with certain immunosuppressants.
February 07, 2024
The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.
February 02, 2024
The UK’s IRP increases flexibility and will help speed up product approvals and patient access to medicines.
January 31, 2024
The immune-resetting peptide, developed by Revolo Biotherapeutics, received positive results from its Phase IIb study.
The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.
January 19, 2024
The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.