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British authorities have warned Reckitt Benckiser that it may have to submit all advertising for vetting if it makes another false efficacy claim for its laxative Senokot. Read More
Despite the FDA extending the comment period for its recommendations on biosimilar labeling, several industry groups have still made public their concerns about the draft guidance. Read More
To drive the development of advanced therapies, industry is asking the European Medicines Agency to provide further guidance, harmonize EU regulations and exercise flexibility. Read More
The European Medicines Agency is offering drugmakers new advice on when to update risk management plans for products with centralized marketing authorization. Read More