Susan Haigney

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.

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.

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

Regulators in the European Union have published the first version a list of critical medicines in the EU to avoid potential shortages.

The product is being voluntarily recalled because of powder leakage due to seal integrity issues.

The agency released two guidance documents on the interim policy on compounding using bulk drug substances for both outsourcing and non-outsourcing facilities.

AstraZeneca will utilize Absci’s AI antibody drug creation platform to create an AI-designed antibody.

The bio/pharmaceutical industry is struggling with the challenge of staffing and training.

Consent decrees were issued against Evig LLC, of St. George, Utah, and Premium Production LLC, of St. George, Utah, for unapproved dietary supplements.

The US District Court for the District of Arizona entered into consent decree against Smart Women’s Choice and its CEO to stop the company from distributing unapproved contraceptive drugs.

The 3M Harvest RC Chromatographic Clarifier, BT500 is the latest addition to the company’s chromatographic clarifier portfolio.

Aitia will access Charles River’s Logica drug solution platform to develop therapeutic programs for neurodegenerative disease and oncology.