Susan Haigney

The facility producer’s new innovation hub will offer manufacturing, life sciences, and infrastructure services.

EMA plans to add 10 partners to its real-world data initiative, DARWIN EU, in 2024.

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

The company is expanding GMP capacities at its Frankfurt site to manufacture early clinical-phase peptide APIs.

Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.

The company is investing more than $250 million into its Bloomington, Ind. Manufacturing site.

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.

Two public electronic catalogues will be available for real-world data sources and for real-world data studies.

The company’s Itasca, Ill., facility will offer chemistry, manufacturing, and controls analytical testing support.

The agency’s safety committee stressed the risk of potential adverse reactions involved with taking Paxlovid (nirmatrelvir, ritonavir) in combination with certain immunosuppressants.

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 CDMOs are joining together to offer end-to-end development and manufacturing services for protein expression systems and viral vectors in Europe.

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

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

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

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

The company issued the recall because of a package mislabeling problem.

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.

Cherwell Laboratories’ cleanroom microbiology solutions will join AnalytiChem’s group of seven companies across Europe, North America, and Australia.

The potential for superpotent drug initiated the voluntary recall.

The expansion will boost solid-phase peptide synthesis total reactor volume to 32,000 L.

The new Europe headquarters will be the hub for the company’s European operations, including production of product.

Analytical methods and tools play a pivotal role in cleaning validation.

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

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.