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Drugmakers developing treatments for uncomplicated vulvovaginal candidiasis should conduct two adequate and well-controlled clinical trials with a superiority design to demonstrate efficacy, the FDA says. Read More
The FDA is pushing for more uniform quality assessments in the clinical development of chewable tablets after finding significant variation among manufacturers. Read More
One week after the FDA tackled compliance with international standards for restricting elemental impurities in finished drugs, the EMA has issued guidance on the same topic. Read More
An FDA advisory committee unanimously recommended FDA approve five indications for Amgen’s biosimilar of the AbbVie’s blockbuster drug Humira. Read More
To drive the manufacturing of advanced therapies, industry is asking the European Medicines Agency to provide further guidance, to harmonize EU regulations and to exercise flexibility. Read More
The European Medicines Agency is recommending that drugmakers update their risk management plans when switching to a new manufacturing process for products with centralized marketing authorization. Read More
The federal appellate court has ruled that the Medicines Company’s use of third-party suppliers to manufacture its blood thinner Angiomax does not invalidate the drug’s patents, reversing an earlier panel decision. Read More