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The European Medicines Agency Wednesday released final guidance on the primary and secondary endpoints sponsors should use to evaluate drugs to treat acute heart failure — along with recommendations on designing and conducting such studies in children. Read More
The FDA has granted breakthrough therapy status for Genentech's scleroderma treatment Actemra, guaranteeing the drug a six-month review rather than the usual 10 months. Read More
The Australian government has developed a framework for measuring the performance of its regulatory agencies, in an effort to increase transparency and cut down on practices that impede the operations of regulated industries. Read More
The FDA is withdrawing approval of one NDA and four ANDAs for ondansetron, effective immediately, due to a potentially life-threatening complication with the drug. Read More
The International Academy of Compounding Pharmacists is urging Congress to require the FDA to revise a memorandum of understanding outlining how states should regulate small compounders, saying the 30 percent a month limit on units sent to other states is unfair and unworkable. Read More
The European Medicines Agency issued revised guidance on classification of advanced therapy medicinal products and the information that sponsors need to submit to the agency. Read More