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.
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,
(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.
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.
Spravato is now the first-ever stand-alone therapy for treatment-resistant depression, and is on its way to becoming a blockbuster product.
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.
Patients with a common heart rhythm disorder who took an experimental blood-thinning drug had far fewer bleeding episodes than patients receiving a standard-of-care blood thinner, a new study has found.