Bacteriophages and AMR, the beginning of a new era?

The newly published EMA draft guideline on the quality aspects of phage therapy medicinal products paves the way for the use in Western Europe of this new - albeit century-old - approach to treating antibiotic-resistant infections

The FDA’s Advanced Manufacturing Technologies Designation Program

The Advanced Manufacturing Technologies Designation Program aims to accelerate the implementation of novel manufacturing technologies and the application of existing ones to new contexts of use. The FDA Guidance for Industry, published at the beginning of January 2025, describes the entire process of submitting a request for AMT designation and its contents