Regulatory Authority Actions

Making Lifecycle Management More Efficient in Europe

April 02, 2024

Plans to update the European Union’s variation framework have been finalized.

Looking at the Potential Impact of JCA on Pharma

April 02, 2024

The European pharma industry needs to be prepared for the new clinical data requirements.

Streamlining Variations

April 02, 2024

A revised regulatory variation framework should make lifecycle management more efficient in Europe.

AstraZeneca Gains FDA Nod for Ultomiris, a Treatment for Managing NMOSD

March 29, 2024

FDA has approved AstraZeneca's Ultomiris, marking the first and only long-acting C5 complement inhibitor for patients with NMOSD.

FDA Greenlights Orchard Therapeutics' Gene Therapy for Children's MLD; AGC Biologics Selected for Manufacturing

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.

Filtration Clarification Needs in Annex 1

March 16, 2024

Misalignment around liquid filtration requirements and contamination control assurance still persist despite the revisions to Annex 1.

FDA Gives Guidance on Developing Treatments for Early Alzheimer’s

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The draft guidance document provides support to sponsors with drugs in clinical development that treat the states of sporadic Alzheimer’s disease.

Updating Swiss Regulatory Processes in 2024

March 02, 2024

Swissmedic issues updated guidance relating to APIs, temporary authorization, and fast-track authorizations.

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.