today announced that its supplemental new drug application (sNDA) of Gvoke VialDx™ has received U.S Food and Drug Administration (FDA) approval for use as a diagnostic aid during radiologic ...

Specialty pharmaceutical company PharmaTher Holdings’ drug application for Ketamine has received a June ... “I am very pleased with the new FDA approval goal date of June 4, 2025, for our Ketamine ...

Aldeyra plans to resubmit the new drug application with new trial data later this year. Perspective from Darrell E. White, MD The FDA issued a complete response letter for the resubmission of the ...

Drug shortages pose a substantial public health threat ... Pipeline Information The Company currently has four abbreviated new drug applications ("ANDAs") on file with the FDA targeting products ...

The new drug application is supported by 3-year data from the STAR study. If approved, SYD-101 would be the first pharmaceutical treatment to slow the progression of pediatric myopia in the U.S ...