FDA

The FDA has approved a new anti-wrinkle treatment called Daxxify. Similar to the popular Botox, Daxxify freezes wrinkles by paralyzing muscles but it lasts at least twice as long, with single injections working for between six and nine months.

The FDA has authorized new mRNA booster shots targeting the BA.4 and BA.5 Omicron variants of SARS-CoV-2. The authorization marks the first updated COVID-19 vaccines to be made available in the US since the original vaccines became available in late 2020.

The US Food and Drug Administration (FDA) has approved the first ever cell-based gene therapy, a one-off treatment for people with a rare genetic blood disease. The treatment will cost US$2.8 million, making it the most expensive medicine in history.

The US FDA has established a new category of over-the-counter hearing aids. The move comes as part of a push by the US government to make healthcare more affordable, allowing millions of people to buy low-cost hearing aids without prescription.

After months of delays the FDA has finally issued an emergency use authorization (EUA) for the Novavax COVID-19 vaccine. Once doses are available this will be the first protein-based COVID vaccine authorized in the United States.

Over the last few weeks the FDA and the WHO have disagreed over what direction COVID-19 vaccines should take later this year. Which Omicron subtype should boosters focus on, and how quickly can vaccine makers deliver new doses?

Biotech company Novavax has revealed its COVID-19 vaccine can generate effective immune responses against all circulating Omicron variants. The unexpected data was delivered to a panel convened by the FDA to recommend booster plans for later this year.

Following years of regulatory delays the FDA has called for all e-cigarette products from Juul to be removed from sale in the US. The FDA cites the reason for the action as “insufficient and conflicting data” in toxicological studies submitted by Juul.

The FDA has followed highly promising results from trials demonstrating the hair regrowth potential of a common arthritis drug with a landmark approval, giving baricitinib the green light as a treatment for severe alopecia areata.

A new direct-to-consumer test designed to detect a number of different respiratory viruses including COVID-19 and influenza has been authorized by the FDA. The test is the first of its kind to be approved that doesn't need a prescription from a doctor.

The FDA has approved a new kind of drug for type 2 diabetes. The once-weekly injection was found to be more effective at controlling blood sugar levels than current treatments, and a recent trial found it also may be useful as an anti-obesity therapy.

The U.S. Food and Drug Administration has approved a new test for Alzheimer’s disease. The test is the first in vitro diagnostic tool for Alzheimer’s to be approved for use in the United States measuring amyloid protein levels in spinal fluid.