Regulatory Oversight and Compliance

EMA Recommends New ALS Treatment

February 27, 2024

The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.

FDA’s Drug Safety Priorities for 2023

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.

FDA Approves Amtagvi, First Cell Therapy for Skin Cancer

February 20, 2024

FDA has approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma.

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.

EMA Accepts Three Organizations into ATMP Pilot Program

February 09, 2024

The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.

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.

AbbVie Gains Nod from NICE for Tepkinly

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.

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 Issues Guidance on CAR-T Cell Product Development

February 01, 2024

The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.