A Prescription Drug User Fee Act target date of September 14, 2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) ...

Aug. 26—Those at risk of a severe allergic reaction always have handy an EpiPen just in case. But soon their life might be saved by a spray in the nose rather than a needle to the thigh. Last week the ...

For the first time, the U.S. Food and Drug Administration (FDA) has approved the use of a ketamine-like drug as a stand-alone ...

A ketamine-based nasal spray is officially the first and only standalone therapy available for treatment-resistant depression ...

Johnson & Johnson’s Spravato nasal spray has been approved to treat a major depressive disorder in adults who have had an inadequate response to at least two oral antidepressants, the FDA announced ...

CARDAMYST is now conveniently available to patients through retail pharmaciesNational sales force hired with promotional ...

The U.S. Food and Drug Administration has expanded its approval of Spravato, an antidepressant nasal spray. The drug is now cleared for use as a standalone treatment for depression. Spravato is made ...

WASHINGTON -- Regulators at the U.S. Food and Drug Administration declined to approve a needle-free nasal spray equivalent to an EpiPen, pending further study, according to the company developing it.

The U.S. Food and Drug Administration (FDA) has approved Johnson & Johnson's nasal spray, Spravato (esketamine), as the first standalone therapy for adults suffering from major depressive disorder ...

The FDA has approved an at-home nasal spray flu vaccine, and it’s now available for order. FluMist enters the bloodstream after being sprayed in your nasal passage and helps build up antibodies to ...