Regulatory Oversight and Compliance

FDA Approves First Recombinant Treatment for Rare Blood Clotting Disorder

November 14, 2023

Adzynma provides a replacement for low levels of the ADAMTS13 enzyme in patients with congenital thrombotic thrombocytopenic purpura.

EMA Recommends Rare Blood Cancer Treatment and Seven Other Medicines

November 13, 2023

Recommended medicines include treatments for generalized myasthenia gravis, glioma, neovascular age-related macular degeneration, and more.

FDA Publishes Guidance on Container Closure Systems for COVID-19

November 09, 2023

The document includes recommendations for the reporting and implementation of changes to container closure system components.

New Biologic Treatment for Hidradenitis Suppurativa Receives FDA Approval

November 03, 2023

This is the second biologic approved to treat HS, a painful and reoccurring skin disease.

The EU AI Act

November 02, 2023

The EU’s AI Act is set to become the world’s first comprehensive legal framework for artificial intelligence.

FDA Provides Guidance on Remote Facility Evaluations

November 01, 2023

The guidance describes the agency’s procedures for performing remote interactive evaluations at drug manufacturing and bioresearch monitoring facilities.

FDA Approves Vaccine for Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents

October 30, 2023

PENBRAYA combines components from two meningococcal vaccines, Trumenba and Nimenrix.

FDA Approves Novel Therapy for Rare Form of Blood Cancers

October 26, 2023

The treatment has received Priority Review designation, as well as FDA Breakthrough Therapy designation and Orphan Drug designation.

EMA Creates Mechanism for Support during Drug Shortages

October 25, 2023

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.

FDA Finalizes Guidance on Development of COVID-19 Vaccines

October 24, 2023

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.