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Sponsors should prepare to submit information on their television marketing operations in an updated Module 1 electronic common technical documents (eCTD) format before the end of the year. Read More
The FDA has for a third time rejected Janssen and Bayer’s push to have their blockbuster blood-thinner Xarelto approved to treat patients with acute coronary syndrome (ACS). Read More
A drug to treat a rare congenital enzyme disorder developed by BioMarin Pharmaceutical became the first product approved by the FDA under its rare pediatric disease priority review voucher program. Read More
Sponsors of new drugs seeking marketing authorization in the EU must now apply to receive a numerical code unique to the application, the European Medicines Agency (EMA) said Tuesday. Read More
A U.S. Food and Drug Administration review of drug approvals and denials over a 12-year period shows many delays could be avoided if drugmakers submitted more accurate and useful information. Read More
After a tough 2013, Teva received good news Jan. 29 as the FDA approved a new formulation of its blockbuster drug Copaxone, helping the product gain new market share as Teva fervently fights off generic competition. Read More
CDER plans to issue highly anticipated guidance in 2014 that addresses specifics about its biosimilars approval pathway and sheds some light on social media usage for pharma companies. Read More
The FDA Feb. 1 began sending status updates to all drugmakers with pending ANDAs to allow them to better estimate when their products can launch. Read More