FDA
Stay current with all the latest and breaking news from FDA, compare headlines and perspectives between news sources on stories happening today. In total, 1,383 stories have been published about FDA which Ground News has aggregated in the past 3 months.Stay current with all the latest and breaking news from FDA, compare headlines and perspectives between news sources on stories happening today. In total, 1,383 stories have been published about FDA which Ground News has aggregated in the past 3 months.
Top FDA News
Europe · WashingtonPfizer Inc and its German partner BioNTech on Monday sought the U.S. Food and Drug Administration's authorization for an Omicron-tailored COVID-19 vaccine booster for children aged 5 through 11 years. The application comes just days after Moderna also applied for FDA authorization of its own Omicron-targeting shot in adolescents aged 12 to 17 years and children aged six to 11. See the Story
Pfizer seeks to expand omicron booster to 5- to 11-year-olds
76% Center coverage: 62 sources
GooglePfizer and BioNtech ask FDA to approve their new Omicron-specific COVID-19 vaccine. The companies submitted an application for emergency use authorization of a 10 microgram dose. The request comes on the heels of applications announced Friday by Moderna.See the Story
Pfizer asks FDA to authorize new COVID booster for children
Coverage: 5 sources
Vaccinations · WashingtonA top vaccine expert and FDA adviser has warned that there is insufficient evidence to recommend the new booster shot for healthy young adults and said it could carry risks.Dr. Paul Offit, MD is an American pediatrician specializing in infectious diseases, vaccines, immunology, and virology. He is also the co-inventor of a rotavirus vaccine.See the Story
FDA vaccine adviser warns healthy young people SHOULDN’T get new bivalent COVID booster
100% Right coverage: 6 sources
Latest News Stories
FDAA Sydney woman is among almost 50 women worldwide diagnosed with newly identified rare cancers linked to breast implants.See the Story
Breast implants linked to rare, aggressive cancers
67% Right coverage: 3 sources
FDAOn September 14, 2022, Food and Drug Administration (FDA) officials reported a new outbreak of infections from Listeria monocytogenes. FDA has not yet identified a particular product linked to the pathogenic bacterial outbreak but has initiated traceback procedures. To date, FDA has confirmed 6 patients from this week’s Listeria outbreak, and the numbers appear to keep rising. It is … Continue reading Ongoing Foodborne Illness Outbreaks Increasi…See the Story
Ongoing Foodborne Illness Outbreaks Increasing - The National Law Forum
FDA · United StatesThe U.S. Food and Drug Administration said on Monday it has authorized an additional five batches of Moderna Inc's updated Covid booster shots made at a Catalent facility in Indiana. Last week, the health regulator had allowed use of ten batches. The FDA had earlier said Moderna had requested authorization for additional batches.See the Story
U.S. FDA clears additional lots of Moderna's Covid booster amid shortage
100% Center coverage: 1 sources
FDASanten and UBE announced the FDA approval of Omlonti for the reduction of elevated IOP in patients with primary open-angle glaucoma or ocular hypertension. The FDA granted the approval on Sept. 22, according to the agency's website. The active ingredient, omidenepag isopropyl, is a relatively selective prostaglandin EP2 receptor agonist.See the Story
FDA approves drop to lower IOP in patients with glaucoma
FDAAustralian company Seer Medical received FDA 510(k) clearance for its at-home electroencephalograph (EEG) system. Seer Home enables patients to undergo week-long studies at home. The data collected is reviewed and annotated by a physician who then produces a report.See the Story
Seer Medical receives FDA 510(k) for its at-home epilepsy diagnosis aide
FDA · United StatesAn adviser to the U.S. Food and Drug Administration (FDA) during an interview advised young people not to receive the recently approved bivalent COVID-19 vaccine booster doses due to a lack of human testing.
Dr. Paul Offit, a member of the FDA’s Vaccines and Related Biological Products Advisory Committee, told CNN this weekend that he isn’t convinced that the new Omicron subvariant-specific boosters will provide any benefit to healthy, younger a…See the Story
FDA Vaccine Adviser Suggests Young Healthy People Shouldn't Get Latest COVID Booster
100% Right coverage: 1 sources
Artificial IntelligenceThe US Food and Drug Administration has granted 510(k) marketing clearance to a new artificial intelligence (AI)assisted polyp detection device for use during colorectal cancer screening. In a clinical trial, the detection rate of adenomas by endoscopists who used the device, which is called SKOUT, was 27% higher.See the Story
FDA Clears New AI Device to Aid Polyp Detection
FDAFDA issued a warning in late June that the PI3 kinase (PI3K) inhibitor may increase the risk of death and serious side effects. The FDA's Oncologic Drugs Advisory Committee (ODAC) reviewed the record for duvelisib for this indication. Of the 12 panelists, eight voted "no" and four voted "yes"See the Story
