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Sponsors hoping to use equivalence criteria in analyzing bioequivalence (BE) studies for their drug applications just got more details on how the FDA wants them to undertake that. Read More
The European Medicines Agency (EMA)’s safety committee has recommended withdrawing medications containing pholcodine, an opioid active ingredient used alone or in combination with other substances, to treat dry cough, cold and flu symptoms. Read More
The most challenging drug shortages the U.S. faces are not the new ones that crop up from illnesses like COVID-19 or the current spike in respiratory illnesses. Rather, the shortages that have been ongoing for years cause the FDA the most strife. Read More
In a deal set to strengthen two different clinical research platforms, Bluebird Bio has sold one of its rare pediatric disease priority review vouchers (PRV) to the immunology company Argenx for $102 million. Read More
In FDA’s ongoing efforts to clean up the accelerated approval (AA) program, the agency has withdrawn approval for an antibiotic cream that’s been on the market for 24 years without its required confirmatory trial to show that the product works. Read More
The FDA has issued a warning letter to a clinical trial site in Illinois for failing to submit an investigational new drug application (IND) before launching a clinical investigation of a combination drug-device product. Read More
Biosimilars with “skinny labeling” saved Medicare $1.5 billion over 5 years, equivalent to almost 5 percent of what the federal system spent on five pricey biologics, according to a new report in JAMA Network. Read More