Tag: Food & Drug Administration
After Appeal, Court Rules Juul Can Still Sell E-Cigarettes for Now
Ruling came in response to the company seeking a temporary emergency hold while it appeals an FDA ban of its products
FDA Bans Juul E-Cigarettes From U.S. Market
Products include the Juul vaping device and four types of Juul pods
FDA to Ban Juul E-Cigarettes From U.S. Markets
Agency has already banned the sale of fruit-flavored e-cigarettes after critics claimed the products targeted teens
FDA Approves Skyrizi for Moderately to Severely Active Crohn Disease
Skyrizi is first specific interleukin-23 approved to treat Crohn disease
New Cancer Drugs Approved Faster in U.S. Than Europe
FDA received licensing applications sooner and had shorter review times, compared to the European Medicines Agency
FDA Panel to Weigh Moderna Vaccine for Those Aged 6 to 17
Regulators have been concerned about reports of myocarditis seen mostly in young men receiving the Moderna vaccine
FDA Approves First Pill to Treat Severe Alopecia Areata
Olumiant is the first FDA-approved alopecia therapy that treats the entire body rather than a specific spot
New ALS Drug Approved in Canada While Still Under FDA Review
Last month, 38 U.S. doctors who treat ALS patients sent a letter urging the FDA to approve the drug
Jif Peanut Butter Recalled Due to Possible Salmonella
Fourteen illnesses (including two hospitalizations) tied to infection; no deaths have been reported
Increased Flexibility Seen in Preapproval Evidence for New Drugs
Twenty-eight percent of trials used historical, external, or other control; nearly half used surrogate measure as a primary end point
