Regulatory Authority Actions

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

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

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

The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate.

The midterm report of the European Medicines Agencies Network Strategy finds that the network has strengthened and is on track to achieve its objectives.

WHO provides a look at the world’s health as the agency turns 75.

The final guidance document provides recommendations for designing a new registry or using an existing registry to support decisions regarding safety and effectiveness of a drug.

The agencies published a joint guidance document regarding quality development for breakthrough therapies and PRIME programs.

The Multi-annual AI Workplan creates a strategy to maximize the benefits and manage the risks of artificial intelligence.

The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.

The US District Court for the District of Massachusetts entered a consent decree of permanent injunction against Pharmasol Corporation for distributing adulterated drugs.

RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.

The new advisory committee will provide the agency with technical and scientific advice and recommendations on potential treatments for genetic metabolic diseases.

Sanofi has issued a statement expressing its disappointment with FTC’s decision to block an exclusive licensing agreement with Maze Therapeutics for a rare disease drug candidate.

Biologics have specific quality considerations that make fast tracking these drugs more difficult.

Exagamglogene autotemcel seen as synechdoche.

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

Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time.

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

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

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

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

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

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

The agency recommended conditional marketing authorization for Elrexfio (elranatamab) as a monotherapy for adult patients with relapsed and refractory multiple myeloma.