FDA

The FDA has approved a new drug for patients in the early-stages of Alzheimer's disease but growing concerns over its safety and real-world efficacy have led to division amongst researchers, with some suggesting it should not be authorized for wide use.

The US Food and Drug Administration (FDA) has approved the first drug that can delay the onset of type 1 diabetes. A recent trial has shown that the drug, named teplizumab, can give patients several extra disease-free years.

The FDA has given California company Upside Foods the green light for its lab-grown chicken, paving the way for it to reach market shelves next year, and making the US the second country in the world to allow legal sales of lab-grown meat products.

The world's first Phase 3 human trial for psilocybin-assisted therapy set to commence by the end of the year. The trial, run by Compass Pathways, will enroll close to 1,000 subjects and the company is looking to FDA approvals by the end of 2025.

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.