FDA approval

The Food and Drug Administration on Thursday issued an emergency use authorization for the first COVID-19 test that uses breath samples. The test, which must be done by a trained operator, can provide...

The lawsuit alleges securities fraud on behalf of investors, adding to the ongoing fallout following Aduhelm’s controversial approval and Medicare’s questionable coverage proposal.

Dry eyes affect nearly 19% percent of adults aged 75 years and older, according to data from a national survey.

One dose of injectable Evusheld may be effective for 6 months, FDA says. The drug neutralizes all previous SARS-CoV-2 variants, and AstraZeneca says it is working to establish its efficacy against the...

EaseVRx is designed for home use and is available by prescription to patients with clinically diagnosed lower back conditions, FDA says.

The new drug, Vuity, adjusts pupil size and corrects near vision without affecting distance vision, drugmaker Allergan says.

Sprayed twice daily into each nostril, Tyrvaya reduced eye dryness within four weeks in clinical trials. The medication will be available by prescription beginning in November, the developer says.

The experimental Alzheimer’s drug gantenerumab is the “first and only” anti-amyloid antibody being investigated for subcutaneous administration and could potentially be given to patients...

Drugmaker AstraZeneca has asked the FDA to authorize what it says could be the first long-acting monoclonal antibody drug therapy for the prevention of COVID-19 in at-risk patients.

Molnupiravir has reduced COVID-19 deaths and hospitalizations by half in a new clinical trial. An orally delivered drug could offer unprecedented treatment convenience, the drug’s developers say.