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Impax Laboratories said it has begun shipping generic Renvela tablets in the U.S. after securing a license from Genzyme to sell a specified number of bottles. Read More
The European Medicines Agency said Monday it has concluded its investigation into deficient postmarket reporting by Roche and forwarded a report to the European Commission, where penalties will be debated. Read More
Drugmakers should include information for all uses of a product — including off-label uses — when preparing periodic benefit-risk evaluation reports, the International Council on Harmonisation says in new Q&A guidance. Read More
The FDA has approved another under-the-tongue hay fever treatment, putting a second product on the market that will replace the routine injections currently prescribed to control symptoms. Read More
U.S. lawmakers are asking the Office of the United States Trade Representative to put Canada back on its priority watch list after the country withdrew a number of patents for drugs sold by American drugmakers. Read More
A federal judge Tuesday overturned Massachusetts’ ban of Zogenix’s controversial painkiller Zohydro ER, saying the state overstepped its authority. Read More
GlaxoSmithKline said Monday it is under investigation in Poland for allegedly bribing doctors to promote the asthma drug Seretide (fluticasone propionate/salmeterol xinafoate). Read More
Drugmakers want the FDA to soften language in its first guidance on social media marketing that would make companies responsible for third-party content. Read More
The FDA has banned imports from active pharmaceutical ingredient maker Canton Laboratories, the fourth Indian drugmaker in a month to be put on import alert for poor quality. Read More
EU member states will be able to purchase pandemic vaccines and other medical countermeasures as a group, under a new procurement scheme adopted Thursday. Read More