Tagged with FDA

USA An up-to-date list of the US FDA’s Center for Biologics Evaluation & Research (CBER)’s biological license application approvals for 2022. There were nine such approvals in 2022, down from 13 in 2021. For the list of non-biological approvals from the FDA’s Center for Drug Evaluation & Research (CDER), click here.…

USA A comprehensive list of the US FDA’s Center for Drug Evaluation & Research (CDER)’s new drug therapy approvals for 2022. CDER approved 37 new drugs in 2022, down from 50 in 2021, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under Biologics…

USA Clinical trial diversity not only allows for a better understanding of the safety and efficacy of new therapies in population subgroups but also plays a significant role in reducing health inequities. In conversation with PharmaBoardroom, outgoing president and global chief executive of the Drug Information Association (DIA) Barbara Lopez Kunz,…

India As one of the world’s a leading pharma manufacturers, India supplies about 20 percent of the global pharmaceuticals demand in terms of volume, yet the industry remains plagued with quality compliance issues. After Sun Pharma, Aurobindo and Zydus found themselves on the FDA’s radar earlier this year, two more Indian…

Global DIA 2022 convened with an opening plenary that explored the question What is the Future of Healthcare? from four connected perspectives—Inclusive, Global, Individual, Digital.   Barbara Lopez Kunz, Global Chief Executive, DIA “We’re here this week because we imagine a world where powerful health interventions and tools are rapidly discovered,…

USA After US life expectancy fell for a second consecutive year, FDA Commissioner, Dr Robert M. Califf, speaking at the recent 2022 Biotechnology Innovation Organization (BIO22) International Convention, discussed what he believes to be the leading cause of death in the United States. Commissioner Califf stated during a fireside chat at…

USA Longtime Director of the Center for Drug Evaluation and Research CDER, Janet Woodcock, will be changing roles at the US Food & Drug Administration (FDA) and moving away from drug regulating. It is still unclear what her new role will entail. Rob Califf, the new FDA commissioner recently announced in…

USA In the United States, clinical trials have long been criticized for inadequate inclusion of minority patients and consequently for not representing the country’s diverse population. The FDA recently released new guidance for improving diversity in clinical trials. According to its Drug Trials Snapshots Report for 2019, of the clinical trials…

WHO Representatives from the US FDA, EMA, WHO and the pharma industry debated over the possible inclusion of environmental impact in future good manufacturing practice (GMP) inspections of drug production sites and the need for a new type of relationship between companies and regulators. We need more information and data to…

USA When the FDA gave Novartis the historic green light for Kymriah – the first gene therapy approved in the United States – in 2017, the agency declared that it was “ushering in a new approach” to the treatment of cancer and other serious and life-threatening diseases. Today, more than 20…

USA A comprehensive list of the US FDA’s Center for Drug Evaluation & Research (CDER)’s new drug therapy approvals for 2021. CDER approved 50 new drugs in 2021, down from 53 in 2020, either as new molecular entities (NMEs) under New Drug Applications (NDAs), or as new therapeutic biologics under Biologics…

USA Pfizer and MSD recently became the latest companies to have COVID-19 treatments authorised by either the US FDA or EMA. Their oral antiviral drugs joined several monoclonal antibodies and others on the list of options available to patients in Europe and the United States. Here is an updated list of…