The Latest Breaking News from FDA

The beleagured Sturgis plant only resumed production less than 2 weeks ago.

Children under the age of five still can’t get vaccinated yet in US

Moderna Inc.’s COVID-19 vaccine for infants and toddlers won the support of a panel of U.S. regulatory advisers, putting parents one step closer to being able to protect their youngest against COVID-19 for the first time.

An outside panel of experts for the FDA recommended both the Moderna and Pfizer vaccine for kids under 5. Shortly after, the FDA granted a EUA.

Children younger than 5 are the last group without access to the shots.

Ahead of Acadia Pharmaceuticals Inc's (NASDAQ:ACAD) FDA AdComm meeting on Friday, the agency officials released their briefing documents, revealing a mixed bag of opinions. The company's resubmitted supplemental New Drug Application for pimavanserin for hallucinations and delusions associated with Alzheimer's disease psychosis (ADP) has a target action date of August 4. Initially, the FDA…

No recall has been issued for the product, but parents are advised not to let newborns and toddlers sleep in the rockers

Gainers Sidus Space, Inc. (NASDAQ: SIDU) shares surged 92.4% to $2.77 after the company announced it is part of Collins Aerospace team which was awarded NASA's Exploration Extravehicular Activity services contract with a potential value of $3.5 billion.

Kintara Therapeutics Inc (NASDAQ: KTRA) shares are trading higher by 28.6% to $0.24 after the FDA granted Fast Track Designation to the company’s VAL-083.