EMA recommended 17 drugs for marketing authorization in December, including treatments for rare heart conditions, anemia, and liver disease.

The Center for Drug Evaluation and Research’s new center will coordinate and promote use of real-word data in regulatory ...

This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, ...

AbbVie has completed its acquisition of Aliada Therapeutics which includes Aliada’s disease-modifying therapy for Alzheimer’s ...

With so many personnel involved in the development and manufacture of pharmaceuticals, proper training of all staff is key to ...

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and ...

The European Commission has developed a roadmap aimed at reversing the rising trend of cancer across the European Union.

Edwin Stone, Bernard Sagaert, and Khaled Yamout go behind the headlines to discuss what the ongoing measles outbreak in the ...

All CGMP requirements, including supporting activities, are critical in aseptic sterile manufacturing to ensure product ...

In this exclusive Drug Digest video interview an industry expert discusses key trends impacting solid dosage drug development ...

Centogene NV and ROPAD consortium publish data from a landmark study identifying genetic variants that may respond to ...

The 340B Drug Pricing Program was created by Congress back in 1992 as a way to help vulnerable patients have access to ...