Advertisement

Topics

FDA Grants Priority Review for Amgen's sBLA for Repatha to Include Data on Reduced Risk for Cardiovascular Events

15:00 EDT 1 Aug 2017 | Drug Discovery Development

The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Dec. 2, 2017.
Contributed Author: 
Topics: 

Original Article: FDA Grants Priority Review for Amgen's sBLA for Repatha to Include Data on Reduced Risk for Cardiovascular Events

NEXT ARTICLE

More From BioPortfolio on "FDA Grants Priority Review for Amgen's sBLA for Repatha to Include Data on Reduced Risk for Cardiovascular Events"

Quick Search
Advertisement
 

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...

Prescription Drugs
A prescription drug (also prescription medication or prescription medicine) is a licensed medicine that is regulated by legislation to require a medical prescription before it can be obtained. The term is used to distinguish it from over-the-counter drug...

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...