Regulatory Authority Actions

EMA and HMA Launch Real-Word Data Catalogues

February 16, 2024

Two public electronic catalogues will be available for real-world data sources and for real-world data studies.

EMA Issues Reminder Over Paxlovid Risks

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.

FDA Provides Guidance on Notifying the Agency of Manufacturing Interruptions

February 07, 2024

The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.

MHRA’s New International Recognition Procedure

February 02, 2024

The UK’s IRP increases flexibility and will help speed up product approvals and patient access to medicines.

FDA Grants Orphan Drug Designation to First-in-Class Treatment for Eosinophilic Esophagitis

January 31, 2024

The immune-resetting peptide, developed by Revolo Biotherapeutics, received positive results from its Phase IIb study.

FDA Give Guidance on Human Genome Editing in Gene Therapies

January 31, 2024

The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.

EMA Looks Back at Medicines Approved in 2023

January 19, 2024

The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.

CDER Approved 55 Novel Drugs in 2023

January 18, 2024

FDA’s Center for Drug Evaluation and Research released its report on new drugs approved in 2023.

EMA Starts Safety Review of CAR T-Cell Medicines

January 17, 2024

The agency is reviewing data on secondary malignancies related to T-cells for approved CAR T-cell medicines.

Precautionary Measures Recommended in Use of Valproate 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.