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Kymriah is considered a gene therapy product where its active ingredient tisagenlecleucel consists of genetically modified white blood cells. Read More
The FDA slapped Dupont Nutrition’s excipient manufacturing facility in Newark, Del., with an eight-observation Form 483 following an inspection in November to December 2021 that revealed inadequate procedures and other quality lapses. Read More
A decision on the composition of a COVID-19 vaccine to be administered to the American population beginning this fall will need to be made by June. Read More
In a study with 1,854 participants, 50 mg of Quviviq led to significant improvements in sleep onset, sleep maintenance and self-reported total sleep time. Read More
The FDA has turned down a citizen petition seeking that the investigators and the institutional review board (IRB) at Minneapolis, Minn.-based Hennepin County Medical Center (HCMC) be barred from conducting clinical trials. Read More
In 2021, the FDA’s Center for Drug Evaluation and Research (CDER) issued fewer warning letters but conducted moregood clinical practice inspections that the previous year, according to the annual report from CDER’s Office of Compliance (OCC). Read More