Tag: Food and Drug Administration

Listeria Outbreak Kills Three in Washington State, Local Health Authorities Say

Three people have died from a listeria outbreak in Washington state, according to state health authorities. The Washington State Department of Health, Tacoma-Pierce County Health Department, and Thurston County Public Health and Social Services announced on July 21 that they were investigating the cases of five adults over 60 years of age who developed severe infections of…


FDA Approves Drug Aimed at Preventing Respiratory Disease in Babies and Toddlers

U.S. drug regulators have approved a drug aimed at preventing a respiratory disease in babies and toddlers. The U.S. Food and Drug Administration (FDA) on July 17 cleared Beyfortus, a monoclonal antibody that prevents respiratory syncytial virus (RSV), a lower respiratory tract disease. Children up to 24 months of age can now receive the drug,…


FDA Panel Recommends Updating COVID-19 Vaccines

Experts on June 15 recommended updating the COVID-19 vaccines due to the current slate performing worse against the XBB variant and its sublineages. Advisers to the U.S. Food and Drug Administration (FDA) unanimously voted to recommend the FDA clear updated shots, less than one year after the vaccines were already updated due to concerns over…


Updated COVID-19 Vaccines Needed Due to Waning Effectiveness: FDA

Newly formulated COVID-19 vaccines are necessary because the performance of the current slate is slipping over time, U.S. officials said this week. “There appears to be an inverse relationship between the time since vaccination and vaccine effectiveness, such that bivalent COVID-19 vaccine effectiveness against Omicron sublineages appears to wane over time,” officials with the Food…


FDA Advisers Back Maternal RSV Vaccine as Pfizer Says Safety Concerns Can be Studied Post-Approval

Advisers to the U.S. Food and Drug Administration (FDA) voiced support on May 18 for Pfizer’s maternal RSV vaccine even after several expressed concerns over premature births. Outside experts on the Vaccines and Related Biological Products Advisory Committee unanimously said data from two trials run by Pfizer were sufficient to support the vaccine being effective at…


‘No Assurances:’ FDA Warns Against Using Eye Drops With Amniotic Fluid

U.S. drug regulators are warning people against using eye drops that have amniotic fluid, as no such products are approved for usage in the United States. Some companies are promoting and selling amniotic fluid eyedrops anyways, claiming they help treat, mitigate, or cure issues such as dry eye disease. “There are currently no FDA-approved amniotic…


FDA: Vaccines Don’t Have to Prevent Infection or Transmission

Vaccines don’t have to prevent infection or transmission to be cleared in the United States, the country’s top regulatory agency said in a new document. “It is important to note that FDA’s authorization and licensure standards for vaccines do not require demonstration of the prevention of infection or transmission,” Dr. Peter Marks, a top official…


Some Americans Shouldn’t Get Another COVID-19 Vaccine Shot, FDA Says

Some Americans cannot receive another COVID-19 vaccine dose, U.S. regulators said on April 18, as they made sweeping changes to the vaccine system. The U.S. Food and Drug Administration (FDA) announced the changes, including replacing the old Pfizer and Moderna vaccines with updated bivalent shots that had previously only been available as boosters. Regulators are…


Biden Administration Asks Court to Block Ruling That Would Make Abortion Pill Unavailable

President Joe Biden’s administration on April 10 asked a U.S. appeals court to stop an order that would make an abortion pill unavailable nationwide on Friday. Making mifepristone, the pill, unavailable would “severely harm women,” Biden administration lawyers told an appeals court in an emergency motion for a stay. U.S. District Judge Matthew J. Kacsmaryk,…


FDA Revokes Approval for Drug for Pregnant Women

U.S. drug regulators on April 6 said they’re withdrawing the approval of a drug aimed at reducing preterm birth in pregnant women. The U.S. Food and Drug Administration (FDA) is withdrawing approval for Makena, which the same agency approved in 2011. The decision stems from the conclusion that there’s no evidence Makena actually reduces the…