U.S. Food and Drug Administration

Good news for public health

U.S. Food & Drug Administration approves world’s first 100% effective HIV prevention drug

The U.S. FDA has approved lenacapavir (Yeztugo), the first HIV prevention shot that’s given just twice a year. In large studies, it was virtually 100% effective—no HIV cases were seen in one trial, and only two cases occurred in another with more than 2,000 people. This long-lasting protection could make it much easier for people to stay protected, especially for those who find taking a daily pill difficult. By reducing the need for frequent dosing, the new treatment has the potential to greatly expand access to HIV prevention and help move the world closer to ending the deadly epidemic that has killed more than 44 million people worldwide since 1981.

Teal Wand - Pap smear alternative

The U.S. FDA approves first at-home tool as a Pap-smear alternative

Traditionally, gynecologists have inserted a cold metal speculum deep into a woman’s vagina to scrape cells from the cervix. The Teal Wand — “built with empathy” by California-based Teal Health — uses a swab to collect a vaginal sample. Women will then mail the sample to a lab that will screen for HPV (human papillomavirus), the virus that causes nearly all cervical cancers. The FDA approval follows a U.S.-based study that found at-home screening was just as effective as that done in a doctor’s office.

Holding pills

U.S. FDA approves non-addictive alternative to opioids

The U.S. Food and Drug Administration has signed off on the first new type of pain reliever to be approved in more than two decades. The drug, suzetrigine, is a 50-milligram prescription pill that’s taken every 12 hours after a larger starter dose. Crucially, suzetrigine creates no euphoria or high like opioids sometimes can, so doctors believe there’s no potential for it to create addiction or dependence in people who use it.

Vials of blood

U.S. Food and Drug Administration approves blood test to screen for colon cancer

The test, known as Shield, isn’t meant to replace colonoscopies, but is generating enthusiasm among doctors who say it has the potential to boost the dismal rate of screenings for the second-highest cause of cancer death in the United States. Shield has previously been available to doctors as a screening tool, at an out-of-pocket cost of $895. With the FDA approval, Medicare and private insurance companies are much more likely to cover the cost of the blood test, making it more widely accessible for patients.