J&J on Tuesday said the green light makes Spravato the first and only monotherapy for adults with major depressive disorder who have had an inadequate response to at least two oral antidepressants.

FDA approves Johnson & Johnson's Spravato nasal spray as a monotherapy for major depressive disorder, showing superior efficacy in clinical trials.

(RTTNews) - Johnson & Johnson (JNJ) Wednesday said it has initiated the submission of new drug application or NDA to Food and Drug Administration (FDA) for TAR-200 to treat patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC).

The U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Johnson & Johnson’s SPRAVATO (esketamine) CIII nasal spray, making the treatment the first and only monotherapy for adults living with major depressive disorder (MDD) who have had an inadequate response to at least two oral antidepressants.

Amid a deluge of executive actions, the Trump administration has directed federal health agencies to pause external communications, such as regular scientific reports, updates to websites and health advisories,

Dr. Dorothy Fink, the acting secretary for the Department of Health and Human Services under President Donald Trump, has instructed the heads of every federal health agency to stop public communication.

The U.S. Department of Health and Human Services has paused public communications until Feb. 1 as Trump appointees take control of health agencies.

The Food and Drug Administration on Tuesday approved Johnson & Johnson's nasal spray to be used alone in adults with a major depressive disorder.

The announcement was welcome news for those with major depressive disorder, affecting an estimated 8.3% of the adult population.

Intra-Cellular has had success selling Caplyta, a brain-rebalancing drug that's approved to treat schizophrenia and bipolar depression.

Drugs used to treat cancer, diabetes and other chronic conditions are among 15 picked for negotiations that could result in lower prices for patients, the Department of Health and Human Services confirmed Friday.