The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...
Serplulimab is the world's first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of ES-SCLC Serplulimab is the first and only anti-PD-1 mAb approved in the European Union (EU) ...
This article is authored by Ranjit Barshikar, CEO, QbD International, CGMP Consulting, United Nations Adviser.
The proposed guidance aims to provide a framework for the approval of personalised mRNA-based cancer vaccines.
Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, ...
A new method has been created for determining N-nitrosamines (NAs) in pharmaceutical preparations using liquid chromatography ...
Dr Reddy's Laboratories has signed a licence agreement with Shanghai Henlius Biotech to develop and commercialise HLX15.
Librela (bedinvetmab injection) is a monthly injectable monoclonal antibody, for which real-world drug experience data has ...
NorthStar, a leading provider of anesthesia care nationwide, is pleased to announce key changes to its executive leadership team as part of its strategy to continue driving the highest quality ...