Tag: Food & Drug Administration
Moderna Asks FDA to Authorize Its COVID-19 Vaccine for Children Under 6
Preliminary analysis indicates vaccine efficacy of 51 percent among children younger than 2 years and 37 percent among children 2 to 5 years
FDA Warns 12 Companies About Skin Lightening Products
There are no FDA-approved or otherwise legally marketed over-the-counter skin lightening products
Use of Extrapolation Common in FDA New Drug Approvals
Extrapolation of the findings from pivotal clinical trials to the approved indication most common for disease severity
Vijoice Granted First Approval for Treatment of PROS
Real-world data show 27 percent of patients with PIK3CA-related overgrowth spectrum treated with Vijoice had radiological response at 24 weeks
New Law Allows FDA to Police E-Cigarettes Made With Synthetic Nicotine
Vaping companies must now follow the same federal sales restrictions and age requirements as tobacco product companies
FDA Advisers Weigh COVID-19 Booster Shots for Fall
Vaccine experts still guessing at what the ever-changing pandemic will bring
FDA Panel Meets to Craft Future Vaccine Strategy
No official vote is planned, and no specific vaccine products will be discussed
FDA Warns of U.S. Norovirus Cases Linked to Canadian Oysters
Oysters were distributed in 13 states, but others may also have received them through further distribution within the United States
FDA Advisory Panel Narrowly Votes Against New ALS Drug
Panelists said they hoped results of a larger study, now underway, would provide more evidence on the drug
FDA Reviewers Give Thumbs Down to New ALS Drug
Agency said results were 'not persuasive,' citing missing data, mistakes in enlisting patients, other issues
