The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...

The HPRA is the national regulator across many different health products: medicines, particularly pharmaceuticals and ...

Hyderabad: CuraTeQ Biologics s.r.o., a step-down subsidiary of Aurobindo Pharma Limited, has announced that the Committee for ...

In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and ...

This article is authored by Ranjit Barshikar, CEO, QbD International, CGMP Consulting, United Nations Adviser.

Authorities in many countries are scrambling for solutions to mounting shortages of medicine. Will any of them work?

The proposed guidance aims to provide a framework for the approval of personalised mRNA-based cancer vaccines.

SHANGHAI, China I 5, 2025 I Shanghai Henlius Biotech, Inc. (2696.HK) announced that its anti-PD-1 mAb, HANSIZHUANG (serplulimab, marketed as ...

Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, ...

High-quality evidence for the treatment of very rare diseases: IQWiG is involved in the EU project RealiseD Developing clinical trials to provide good evidence for very rare diseases, so that ...

The Sterile Injectable Contract manufacturing market is expected to grow from an estimated USD 16.54 bn in 2024 to USD 34.77 bn in 2033, at a CAGR of 8.50%.

A new method has been created for determining N-nitrosamines (NAs) in pharmaceutical preparations using liquid chromatography ...