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An FDA advisory committee unanimously recommended the agency approve five indications for Amgen’s biosimilar of AbbVie’s blockbuster drug Humira. Read More
With an eye toward advancing personalized medicine, the FDA is mapping out the development of therapies with companion devices, offering companies a slew of pathways. Read More
EMA is proposing a broader scope for guidelines on initial human trials to address emergent practices and safety issues linked to participant deaths. Read More
An FDA advisory committee unanimously backed FDA approval of Valeant’s Siliq to treat plaque psoriasis, but was split on the risk management of the candidate due to reported suicides. Read More
The data integrity issues most likely to lead to a delay in FDA marketing approval for new drugs include poor quality control for data entry, systemic errors at clinical study sites and database changes made after an initial database lock and study unblinding. Read More
Randomized controlled trials have long been the standard for efficacy claims, but a new report calls on the FDA to lay out terms for using real-world data in the drug approval process. Read More
As the life science industry waits for Brexit to be formalized, regulatory compliance experts foresee a standstill in the country’s research and development. Read More
An FDA advisory committee recommended the approval of Merck’s bezlotoxumab to prevent Clostridium difficile infection recurrence in patients 18 and older. Read More
The FDA is providing recommendations on clinical trial designs for sponsors developing antiviral drugs to prevent and treat herpes-related sores that form around the mouth. Read More