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) ...

As previously disclosed, Scienture, LLC, a wholly-owned subsidiary of Scienture Holdings, Inc., entered into a definitive agreement with Summit Biosciences Inc. (a Kindeva subsidiary) in March 2025, ...

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 ...

The FDA has approved an esketamine nasal spray for the treatment of depression cases that do not respond to other therapeutic approaches. Image credit: Koldunov/Getty Images. Hundreds of millions of ...

Add Yahoo as a preferred source to see more of our stories on Google. Johnson & Johnson’s Spravato nasal spray has been approved to treat a major depressive disorder in adults who have had an ...

The US Food and Drug Administration (FDA) has approved a supplemental new drug application allowing esketamine nasal spray (Spravato; Johnson & Johnson) to be used as a standalone treatment in adults ...

This is an archived article and the information in the article may be outdated. Please look at the time stamp on the story to see when it was last updated. U.S. health officials on Friday approved a ...

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 ...

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 ...

Milestone ® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that a moderated ...

FILE - Food and Drug Administration (FDA) building is shown in Silver Spring, Md., Dec. 10, 2020. (AP Photo/Manuel Balce Ceneta, File) (Manuel Balce Ceneta, Copyright ...

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 ...