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Delegates from more than 20 countries in Latin America and the Caribbean are calling for comprehensive health and medicines policies and strategies that provide long-term, sustainable and effective solutions for ensuring access to life-saving drugs. Read More
The U.S. Food and Drug Administration has banned imports of drugs made at Mumbai, India-based Polydrug Laboratories, marking the latest development in ongoing issues involving Indian manufacturers. Read More
The FDA has asked Amicus Therapeutics to integrate data from two Phase 3 studies of its Fabry disease treatment migalastat, pushing back its NDA filing until early 2016. Read More
U.S. companies taking new biologicals to 11 Pacific Rim nations would get no more than eight years of marketing exclusivity — four less than what they enjoy in the U.S. — under a trade deal agreed to by all 12 countries. Read More
The Federal Trade Commission is taking drugmakers to task for tweaking products to maintain exclusivity and block generic competition, warning the practice — known as product hopping — may violate antitrust laws. Read More
A federal judge agreed with the FDA’s interpretation that marketing exclusivity begins with NDA approval — and not the date of controlled substance scheduling — rejecting Eisai’s bid to restore exclusivity for two of its drugs. Read More