FDA

The FDA has approved the first cell-based gene therapies for treating sickle cell disease, one of which is the first approved therapy to utilize the CRISPR/Cas9 gene editing technology. It signals advancements in gene therapy and regenerative medicine.

The US has officially got a homegrown hero in the burgeoning global industry of effective weight-loss treatment, with the FDA approval of Lilly’s Zepbound. The company has revealed its cost, dosages, insurance subsidies and when it will be on shelves.

With an industry expected to be worth US$100 billion by 2030, a supply crisis, slow manufacturing processes, and a high price tag, it's no surprise the much-hyped class of injectable weight-loss drugs has become a prime target for counterfeit trade.

Adding weight to the large body of scientific evidence that has found phenylephrine is as useless as a placebo for nasal congestion, an advisory panel has declared common oral medications ineffective and urged for them to be removed from sale.

The US Food and Drug Administration recently fast-tracked its approval of brexpiprazole (Rexulti), an antipsychotic for treating agitation in dementia patients, when clinical studies demonstrated an increased risk of death and no meaningful benefit.

A debate has raged for decades as to whether a common artificial sweetener, aspartame, causes cancer. While the World Health Organization has now said it 'possibly' does, experts argue there's little evidence to support this and that it's still safe.

The first Alzheimer’s disease medication shown in trials to slow progression of the disease by 27% has been given full approval by the Food and Drug Administration, paving the way for its costly price tag to be covered by Medicare.

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.