Topics

FDA Approval Sought for Extended Pembrolizumab Dosing Schedule for Select Indications

10:39 EDT 9 Jul 2019 | OncLive

The FDA has accepted 6 supplemental biologics license applications for review to update the dosing schedule for pembrolizumab (Keytruda) to include an every-6-weeks option at 400 mg over 30-minute infusions.

Original Article: FDA Approval Sought for Extended Pembrolizumab Dosing Schedule for Select Indications

NEXT ARTICLE

More From BioPortfolio on "FDA Approval Sought for Extended Pembrolizumab Dosing Schedule for Select Indications"

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...

Biotherapeutics
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. ...