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 ...

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 ...

FDA's approval will allow Kedrion to manufacture Ryplazim (plasminogen, human-tvmh), the only FDA-approved therapy for treating PLGD-1, at facility in Bolognana, Italy.

Pharmaceutical Technology® spoke with Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River ...

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 ...

The European Commission has approved Novo Holdings' acquisition of Catalent, which includes the related sale of three manufacturing sites to Novo Nordisk, which is also acquiring the Czech Republic ...

This article presents an overview of FDA’s recent update to the guidance document, Control of Nitrosamine Impurities in Human Drugs.

The European Commission has approved Novo Holdings' acquisition of Catalent, which includes the related sale of three manufacturing sites to Novo Nordisk, which is also acquiring the Czech Republic ...

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study. It is ...

Shilpa Gadgil, PhD (VP, Head of Process and Analytical Development, Head of CDMO Development) discusses Enzene's new technologies and the New Jersey site capabilities.