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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
When given the opportunity to use real-world data for drug approvals, sponsors scramble to conceive innovative approaches, an EMA official said. 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