Regulatory
President Joe Biden has nominated former U.S. Food and Drug Administration Commissioner Robert Califf to reprise his role at the agency’s helm.
Between January 4, 2020 and October 30, 2021, COVID-19 accounted for 576 deaths among children 17 and younger, compared to 189 from influenza, according to the CDC.
Pfizer and BioNTech requested the FDA authorize booster shots for their COVID-19 vaccine for all adults 18 years and older, presenting data not available in September.
Mid-November is a relatively quiet period for the U.S. Food and Drug Administration in terms of its scheduled PDUFA dates. Read on for more.
Ardelyx, Inc. is lacing up the gloves and preparing to wade into the ring with the U.S. Food and Drug Administration to dispute the July rejection of its chronic kidney disease drug, tenapanor.
The FDA informed Moderna that it would need more time to evaluate the company’s Emergency Use Authorization (EUA) submission for its COVID-19 vaccine for adolescents 12 to 17 years of age.
The U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine for children ages 5 to 11.
Yet another busy week for clinical trial news. Here’s a look.
Paris-based Sanofi reported its third-quarter finances, with most of its categories showing strong growth. However, not everything was rosy
The osteoarthritis drug tanezumab gets permanent leave from the market. The decision of stopping production was due to negative feedback from the regulators.
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