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The FDA Tuesday released new information that shows the scope of its efforts to investigate the efficacy and bioequivalence of generic drugs, publishing summaries of ongoing research. Read More
Preliminary data from a late-stage trial of Eli Lilly’s type 2 diabetes drug dulaglutide positions the candidate as a major contender in the increasingly competitive drug class known as GLP-1. Read More
Amarin has received more bad news from the FDA, which granted its prescription fish oil pill just three years of exclusivity instead of five — a decision limiting market power for the drug as it struggles to win an expanded indication. Read More
The FDA is proposing to extend new chemical entity (NCE) market exclusivity for certain fixed-dose combination (FDC) drugs from three to five years, bowing to industry and congressional demands that more incentives are needed to pursue the costly products. Read More
After operating its OTC drug review process largely unchanged for 40 years, the FDA has concluded the process needs an overhaul to address long-standing problems. Read More
European regulators have turned down drugmakers’ requests to allow generic labeling of pandemic vaccines, which sponsors argue would help get their drugs to patients much sooner. Read More