FDA plan to fast-track Pfizer vaccine for kids under 5 fails

Parents of children under 5 will have to wait until at least April to get their kids vaccinated against Covid-19, after the Food and Drug Administration and Pfizer this week abruptly delayed plans to get the shots authorized on a fast-track basis. The FDA had originally planned to authorize the first two doses of what … Read more

Pfizer delays FDA application to expand Covid vaccine to kids under 5 until April

Pfizer and BioNTech on Friday said they were delaying their request for the Food and Drug Administration to authorize their Covid-19 vaccine for children under 5 until early April, waiting on more data on the effectiveness of a third dose. “Given that the study is advancing at a rapid pace, companies will wait for the … Read more

FDA committee votes against Eli Lilly cancer treatment over concerns trials conducted only in China

The outside of the Food and Drug Administration headquarters is seen in White Oak, Md. Al Drago | CQ Roll Call | Getty Images A Food and Drug Administration committee on Thursday recommended against full approval of a lung cancer treatment developed by Innovent Biologics and Eli Lilly over concerns the clinical trial was conducted … Read more