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The FDA is continuing its push to help drugmakers better understand how they can use the agency’s expedited approval programs, releasing new details on how agency staff will review certain drugs in the breakthrough therapy pathway. Read More
In a blow to AbbVie’s efforts to head off generic competition on its AndroGel 1%, the FDA said Irish drugmaker Perrigo’s testosterone gel product is bioequivalent and interchangeable. Read More
Sandoz has become the first drugmaker to announce FDA acceptance of a biosimilar application with its cancer treatment filgrastim, a milestone that indicates the highly anticipated class of products may soon come to market more than four years after Congress approved a regulatory pathway. Read More
The FDA yesterday approved an expanded indication for Janssen and Pharmacyclics’ blood cancer drug Imbruvica to treat chronic lymphocytic leukemia patients who carry a deletion in chromosome 17, which makes them resistant to standard CLL treatments. Read More
In a significant shift in its electronic submission policy, the FDA will require drugmakers to submit certain drug master files and all advertising and promotional materials electronically by 2016. Read More
Drugmakers operating in the EU must submit additional information on their authorized products to the European Medicines Agency, starting immediately, and update previously submitted information by year’s end, according to requirements that took effect June 16. Read More
Sponsors of clinical studies in the European Economic Area ending on or after July 21 of this year must post summary results on the EudraCT clinical trials database by the following July, another step in Europe’s move toward greater trial transparency. Read More