Tag: Food & Drug Administration
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
FDA Moves to Ease Nationwide Shortage of Baby Formula
The agency's latest moves should help ease the dire situation many mothers face
Company Hid Problems With COVID-19 Vaccines From FDA
Nearly 400 million doses of vaccine made by Emergent had to be destroyed 'due to poor quality control'
FDA Warns of Counterfeit Home COVID-19 Test Kits
Two fakes the FDA knows of are counterfeit Flowflex COVID-19 test kits and iHealth Antigen Rapid Test Kits
FDA Proposes Ban on Menthol Cigarettes, Flavored Cigars
Research has shown that menthol cigarettes are harder to quit than traditional tobacco products
