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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
Government auditors Monday criticized the FDA for its ongoing drug shortages problem, while House lawmakers chastised the agency at a hearing for not taking more action. Read More
A new data standard being proposed by the Clinical Data Interchange Standard Consortium could give sponsors and FDA reviewers greater flexibility to analyze data, if adopted by the agency for drug review applications. Read More
The FDA’s breakthrough therapy program is proving its potential to advance new drugs and biologics targeting unmet needs, a new Tufts University report says. But industry interest in the year-old program may wane if the approval times for breakthrough drugs don’t improve. Read More
Companies producing vaccines in the EU to protect against annual flu strains will not need to conduct pre-approval clinical trials to support vaccine applications beginning with the 2015/2016 flu season. Read More