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FDA Commissioner Robert Califf has said the FDA still has a lot of work to do with regard to the pandemic, and in particular, he doesn’t think the agency is doing enough with COVID-19 therapeutics. Read More
One day after Pfizer CEO Albert Bourla said physicians could prescribe a second course of the company’s oral COVID-19 treatment Paxlovid to patients who suffer a rebound, the FDA refuted the executive’s statement. Read More
By rejecting the national settlement, the state gained an extra $46 million to help pay for substance abuse treatments and other strategies to address the opioid crisis, said State Attorney General Bob Ferguson. Read More
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