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March 20, 2024
FDA's approval makes Orchard Therapeutics' Lenmeldy (atidarsagene autotemcel) the first gene therapy approved to treat pediatric metachromatic leukodystrophy in the US.
March 16, 2024
Misalignment around liquid filtration requirements and contamination control assurance still persist despite the revisions to Annex 1.
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The draft guidance document provides support to sponsors with drugs in clinical development that treat the states of sporadic Alzheimer’s disease.
March 02, 2024
Swissmedic issues updated guidance relating to APIs, temporary authorization, and fast-track authorizations.
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.