The Food and Drug Administration (FDA) on Wednesday authorized the first-ever condom intended for safe anal intercourse. Authorization of the One Male Condom is expected to help reduce the transmission of sexually transmitted infections (STIs), including HIV/AIDS in both anal and vaginal intercourse, the
Biden’s FDA pick finds himself in tough confirmation battle
Dr. Rob Califf, a longtime cardiologist, was last confirmed to run the sprawling agency during President Barack Obama’s final year in office by an 89-4 vote. But it has been challenging for Califf to find anywhere near the same level
FDA investigating outbreak of listeria infections connected to Fresh Express packaged salads
Ten people have become ill, 10 have been hospitalized and one person has died across eight states in the listeria outbreak. The illness started between July 2016 and October 2021, the FDA said. The recall comes after the Michigan Department
FDA will allow abortion pills to be permanently available by mail
The Food and Drug Administration said Thursday that it would permanently remove a key restriction on medication used to terminate pregnancies, allowing so-called “abortion pills” to be available by mail and prescribed through telehealth medical consultations. The FDA had temporarily allowed the medication
Pfizer to Seek FDA Approval for COVID Boosters for Ages 16–17
Caitlyn Jendrejas, 15, receives her second dose of the Pfizer vaccine from pharmacist Shane Dixon at the Watson Pharmacy in Fordyce, Ark., August 12, 2021. (Shannon Stapleton/Reuters) Pfizer and BioNTech are expected to request approval from the Food and Drug
The F.D.A. could authorize Moderna boosters for all adults as early as this week.
Moderna has asked federal regulators to authorize booster shots of its coronavirus vaccine for all adults, a request that the Food and Drug Administration could grant as early as this week along with a similar request from Pfizer, according to
Biden picks former FDA Commissioner Dr. Robert Califf to run the agency
Dr. Robert Califf testifies during his nomination hearing before the Senate Health, Education, Labor and Pensions Committee November 17, 2015 in Washington, DC. Win McNamee | Getty Images President Joe Biden announced Friday he has nominated Dr. Robert Califf to
Here’s what happens next if an F.D.A. panel recommends pediatric Covid shots.
An independent committee of experts advising the Food and Drug Administration is meeting on Tuesday for discussion whether to recommend authorizing the Pfizer-BioNTech coronavirus vaccine for children 5 to 11 years old, which could open the way to inoculating 28
F.D.A. Panel Recommends Booster for Many Moderna Vaccine Recipients
Some experts questioned whether Moderna had gathered enough data on potential side effects. Regulators and scientists have been especially concerned about the risks of the heart conditions myocarditis, or inflammation of the heart muscle, and pericarditis, or inflammation of the
An F.D.A. panel is set to meet on Moderna boosters.
A key federal advisory committee is set to begin two days of meetings that are expected to strongly influence decisions on whether at least some recipients of the Moderna and Johnson & Johnson coronavirus vaccines will soon be eligible for
AstraZeneca asks the F.D.A. to authorize an antibody treatment to prevent Covid-19.
AstraZeneca said on Tuesday that it had asked the Food and Drug Administration to grant emergency authorization for a long-acting antibody treatment to prevent Covid-19 in people who are at high risk of the disease. If authorized, it would become
Following expert advice, FDA authorizes boosters for people 65+, high risk
Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. Covid-19 Coverage View more stories The US Food and Drug Administration late Wednesday authorized booster doses of the Pfizer/BioNTech COVID-19 vaccine for people ages 65 and up. Also
FDA advisors green-light Pfizer boosters for people 65+ and at-risk groups
Enlarge / Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech. Covid-19 Coverage View more stories A committee of independent advisors for the Food and Drug Administration has voted unanimously (18 to 0)
Tension over boosters rises as FDA regulators quit and publicly blast Biden’s plan
Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. Two leading vaccine regulators who had previously announced their resignations from the Food and Drug Administration have now come out against the Biden administration’s plan to offer COVID-19
Anger, frustration at FDA over Biden’s booster plan; two top regulators resign
Enlarge / The US Food and Drug Administration in Silver Spring, Maryland. Covid-19 Coverage View more stories Two top vaccine regulators have resigned from the Food and Drug Administration, revealing anger, frustration, and turmoil at the federal agency as it