FDA

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.

The first breath-based COVID-19 test has been issued an emergency use authorization by the FDA. The device takes three minutes to return results and has been found to be over 90 percent accurate in detecting positive COVID-19 cases.

The FDA has authorized a Fitbit feature designed to continuously monitor a wearer’s heart rhythms for signs of arterial fibrillation. The roll-out is based on a study that last year reported the algorithm detects 98 percent of irregular heart rhythms.

New CDC modeling estimates the BA.2 Omicron variant is now dominant in the United States. In related news the FDA has withdrawn its emergency authorization for the COVID-19 antibody treatment sotrovimab as research has found it ineffective against BA.2.

The FDA has authorized a fourth mRNA vaccine dose for all individuals aged 50 and over. The authorization includes both Pfizer and Moderna vaccines and is recommended to be administered at least four months after a third dose.

The FDA has issued an emergency use authorization for bebtelovimab, a monoclonal antibody designed to reduce risk of hospitalization and death from COVID-19. This comes after previous antibody treatments were found to be ineffective against Omicron.

Delta-8 THC is similar to its commonly known psychoactive cousin, delta-9 THC, and new studies are offering the first large-scale insights into what kinds of effects people are experiencing with this unique and under-researched drug.

The first oral treatment designed specifically for COVID-19 has been authorized for use in the US by the FDA. Called Paxlovid, the treatment is recommended for those at high risk of severe COVID-19 and is to be taken within five days of symptom onset.

The first FDA-approved eye drops to treat age-related blurry near vision (presbyopia) has gone on sale in the US, offering a potential alternative to reading glasses for the estimated 128 million Americans affected by this common condition.

Ahead of a FDA advisory panel meeting, drugmaker Merck has revealed final analysis data from a Phase 3 trial testing its oral antiviral pill against COVID-19. The new data reveals the treatment is significantly less effective than early indications.