Regulatory Authority Actions

Imfinzi (durvalumab) combined with chemotherapy decreased the risk of disease progression or death by 58% in a 700-patient trial.

CDER's new program will create discussion around AI and be administered through the Emerging Drug Safety Technology Program.

Breyanzi is made from the patient’s own T cells, which are genetically reengineered into CAR-T cells and then delivered through infusion as a one-time treatment.

The BioMaP-Consortium includes members of the biopharmaceutical industry and supports BARDA.

The outcomes of a workshop organized by WHO and ICMRA regarding COVID-19 vaccine strain updates are presented in a report published by regulators.

AstraZeneca notes that Ultomiris is the first and only long-acting C5 complement inhibitor that offers NMOSD patients the potential to live without relapsing.

AbbVie’s acquisition of Landos includes a lead asset that boosts its portfolio in autoimmune and inflammatory diseases, while the ADC, ELAHERE, gets full FDA approval.

Orchard Therapeutics’ Lenmeldy (atidarsagene autotemcel) marks the first gene therapy approved in the US for treating children with metachromatic leukodystrophy.

FDA published the draft guidance to support sponsors in developing treatments for the states of sporadic Alzheimer’s disease.

The agency has published final guidance documents regarding validation and development of analytical procedures.

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 FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.

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

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

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

The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.

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

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

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.