Case Study: USFDA The Limited Population Pathway and approval of Arikayce
The US Food and Drug Administration late Friday granted accelerated approval of Arikayce (amikacin liposome inhalation suspension), developed by US biotech Insmed,... Read More
USFDA approval of patisiran, first-of-its kind targeted RNA-based therapy
The U.S. Food and Drug Administration today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary... Read More
How many new drugs approved in 2015 against 2014 and 2013?
The FDA approved 45 novel new drugs in 2015 compared to 41 in 2014 and 27 in 2013. 2015 – 45 New... Read More