FDA authorizes 3-minute breath test to detect COVID
By
Amy Novotney
Apr 18, 2022
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...
Biogen hit with class-action lawsuit involving Alzheimer’s drug Aduhelm
By
Alicia Lasek
Feb 10, 2022
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.
After 20 years on the market, AbbVie’s dry-eye drug Restasis to be available as generic
By
Alicia Lasek
Feb 03, 2022
Dry eyes affect nearly 19% percent of adults aged 75 years and older, according to data from a national survey.
FDA OKs first injectable antibody drug to prevent COVID-19 in the vulnerable
By
Alicia Lasek
Dec 10, 2021
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...
FDA approves virtual reality system for treatment of chronic back pain
By
Alicia Lasek
Nov 17, 2021
EaseVRx is designed for home use and is available by prescription to patients with clinically diagnosed lower back conditions, FDA says.
FDA approves first-ever eye drop that corrects age-related vision loss
By
Alicia Lasek
Nov 02, 2021
The new drug, Vuity, adjusts pupil size and corrects near vision without affecting distance vision, drugmaker Allergan says.
FDA approves first nasal spray for chronic dry eyes
By
Alicia Lasek
Oct 19, 2021
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.
Alzheimer’s drug designed for ‘at-home’ use scores FDA breakthrough designation
By
Alicia Lasek
Oct 12, 2021
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...
A first? COVID antibody therapy with full-year protection is up for FDA authorization
By
Alicia Lasek
Oct 08, 2021
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.
Merck to seek emergency use for COVID-19 antiviral pill that cuts severe outcomes by 50 percent
By
Alicia Lasek
Oct 04, 2021
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.