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Johnson & Johnson is pulling its OTC nausea and vomiting drug domperidone from the UK market following a decision by regulators that the medicine must require a prescription to obtain due to risks of serious cardiac effects. Read More
Starting this month, active substances found only in medicines authorized at the country level in the EU are subject to centralized review of period safety update reports by the European Medicines Agency. Read More
A federal judge has ruled that Par Pharmaceutical’s generic version of the Novartis Alzheimer’s treatment Exelon Patch did not infringe on the brand manufacturer’s patent. Read More
Biological manufacturers should submit their lot distribution reports (LDRs) using the same electronic messaging standard as those used for drug registration and labeling content of BLAs, says a new draft guidance on LDR electronic submissions. Read More
San Francisco-based drugmaker Exelixis is halting research into the use of its thyroid cancer therapy Cometriq for treating prostate cancer after the drug failed a Phase III trial for that indication. Read More
Sandoz must wait until a patent on United Therapeutics Corporation’s pulmonary arterial hypertension drug Remodulin expires in 2017 before it can market a generic version. Read More
Martin Avenue Pharmacy is recalling all of its unexpired sterile preparations and stopping production of sterile drugs after FDA investigators discovered contaminated products and evidence of poor quality control. Read More
Shuttered Boehringer Ingelheim subsidiary Ben Venue continues to create quality headaches for the German manufacturer with the recall of a chemotherapy drug due to a container defect. Read More