Review time for Samsung's cancer drug extended by FDA

04:54 EST 9 Nov 2018 | SmartBrief

The FDA required an extension of three months to review Samsung Bioepis' biologics license application for cancer drug SB3, a -More

Original Article: Review time for Samsung's cancer drug extended by FDA


More From BioPortfolio on "Review time for Samsung's cancer drug extended by FDA"

Quick Search


Relevant Topics

Drug Approvals
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...

The field encompassing therapeutic materials produced using biological means, including recombinant DNA technology. Biotherapeutics, also known as biotech drugs or biologics, are therapies derived from living organisms. By harnessing these living cells...

Collaborations in biotechnology
Commercial and academic collaborations are used throughout the biotechnology and pharmaceutical sector to enhance research and product development. Collaborations can take the form of research and evaluation agreements, licensing, partnerships etc. ...