The Latest Breaking News from Food and Drug Administration

Partners Pfizer, Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) urged the FDA to authorize three vaccine doses for children below five, the Wall Street Journal reports. The companies previously asserted that three doses of the shot were 80% effective at preventing symptomatic Covid-19 with robust immune response in children between six months to five years. After mixed results…

The Food and Drug Administration is launching a phone app and a website for people to register their cultivation of cannabis and hemp plants, which are being removed from the category 5 narcotics list, FDA deputy secretary-general Withid Sariddeechaikool said on Wednesday.

May turned out to be a month of mixed fortunes as far as regulatory reviews are concerned. New molecular entity approvals, an indicator of innovation in drug research, totaled three during the month, bringing the total for the year to 15. This compares to the 24 NMEs the Food and…

Plus: Libertarian Party changes abortion and bigotry planks, the FDA's weird rejection of fluvoxamine for treating COVID-19, and more...

The Public Health Ministry has signed an agreement with eight agencies to emphasise the use of cannabis and hemp for medical, beauty and research and development use amid fears people will use it for recreational purposes when they are allowed to grow the plants at home from June 9.

COVID-19 case numbers are rising again in the U.S. – including among children. In mid-May 2022, the Food and Drug Administration authorized a booster shot of the COVID-19 vaccine for U.S. children ages 5 to 11, and the Centers for Disease Control and Prevention followed by recommending a booster shot…

Elevation Oncology, Inc. (NASDAQ: ELEV) received Fast Track designation from the Food and Drug Administration (FDA) for Seribantumab in tumor-agnostic settings for the treatment of advanced solid tumors that harbor NRG1 gene fusions.

Millions more cans of baby formula will be available in the U.S. in the coming months, the nation’s Food and Drug Administration said, detailing steps it’s taken to alleviate a shortage that has left families scrambling to figure out how to feed their babies.

The head of the Food and Drug Administration is preparing to tell lawmakers about events that led to a months-long gap before inspecting the plant at the center of a nationwide baby formula shortage

Pfizer plans to submit new data to the Food and Drug Administration this week, bringing families with young children one step closer to a long-awaited vaccine.

The J.M. Smucker Co. announced the recall on Friday. The Food and Drug Administration says current epidemiologic evidence points to a Lexington, Ky., facility as the likely cause of the outbreak.