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

Colin McKinlay, the senior director of Chemistry and Delivery Technologies at Nutcracker Therapeutics, discusses current challenges in mRNA and LNP manufacturing as well as innovations that meet these ...

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

The company will be showcasing its injection blow molded bottles and five-layer blown film at the packaging event in Paris on Jan. 22–23, 2025. TekniPlex Healthcare, a contract development and ...

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

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

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

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

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

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

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

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