Tag: Food & Drug Administration
FDA Approves First Pill for Fecal Transplant Therapy
Vowst is approved to prevent recurrence of C. difficile; pill contains live gut bacteria from stool samples donated by healthy people
FDA Approves Drug for Rare Form of ALS
Agency approved the drug based on evidence of a reduction in plasma neurofilament light; no evidence the drug slowed the disease
FDA Withdraws Approval of Drug Meant to Prevent Preterm Births
Agency has formally withdrawn the approval of Makena over a lack of effectiveness and serious side effects that include blood clots, depression
New Nasal Spray for Migraines Approved by FDA
About 40 percent of trial participants who took the medication were free of their worst symptoms two hours after using the medication
FDA Takes Action Against Animal Tranquilizer Tied to Fatal ODs
Xylazine -- used to sedate large animals such as horses and deer -- is sold on the street under the names tranq, Philly dope, and zombie drug
FDA Approves First Home Test to Detect Both Flu and COVID-19
Test will be sold without a prescription and can be used by anyone 14 years and older or by an adult on children ages 2 years and older
After Criticism, FDA Pledges to Revamp Its Tobacco Division
Agency has faced criticism from antitobacco advocates, the industry, and lawmakers for its past work in cigarette and vaping regulation
10 Percent of New Drugs Approved Without Meeting Primary Efficacy End Points
Findings seen for 21 drug approvals between 2018 and 2021, with only one-third needing postmarketing studies
After Baby Formula Scandal, FDA Announces New Unit Focused on Food Safety
Agency will also create a new Center for Excellence in Nutrition to better inform Americans about the nutritional value of everyday foods
FDA Says No to Regulating CBD Products as Supplements
How to regulate CBD supplements has become a pressing public health concern as the popularity of CBD supplements has exploded in the United States
