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

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

FDA proposes draft guidelines on AI use in drug development, addressing challenges and opportunities for improving safety and ...

New EU regulations aim to speed up health technology assessments (HTAs), but the pharma industry raises logistical concerns.

Granted IMC-G.A.P. Equivalency Certification by Control Union (“CU”)Milestone to export to Israel and EU-GMP facilities in ...

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

The Global Vial Adaptors for Reconstitution Drug market is poised for substantial growth, reflecting strong financial projections and industry expansion. In 2023, the market was valued at USD 2,186.69 ...

The Global Vial Adaptors for Reconstitution Drug Market is poised for substantial growth, reflecting strong financial projections and industry expansion.

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 ...

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

The global biosensors market was valued at $26.75 billion in 2022 and is projected to reach $45.95 billion by 2030. This ...

In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and clinical studies and managing chemistry, manufacturing, and controls (CMC) ...