… generic drug maker Lupin Abbreviated New Drug Application (ANDA) for Tolvaptan tablets has received … US Food and Drugs Administration (FDA). The Tolvaptan is a generic …

… CRL”) from the FDA for the resubmission of the New Drug Application (“NDA”) of reproxalap … the prospects for FDA approval of the NDA of reproxalap. In … : “the FDA stated in the letter that the NDA ‘failed to … trial submitted to the NDA that may have affected …

… approval from the U.S. FDA for the product. File | Photo … and Drug Administration (U.S. FDA) to manufacture and market Dasatinib … said. This is the 181st ANDA approval, including nine tentative approvals …

… inhalation powder. Liquidia’s NDA referenced Tyvaso®, but while … study. Subsequent to approval, FDA determined that Tyvaso DPI® qualified … to the approval of the NDA. FDA found that Tyvaso DPI® … must meet two requirements: FDA cannot have previously relied on …

… .S. and Asia, and submitted new drug applications (NDAs) in 11 Asia Pacific …

… Administration (NMPA) has approved the New Drug Application (NDA) for limertinib as the … the market. It has 3 new drug applications under regulatory review, 4 assets …

… Administration (NMPA) for its supplementary New Drug Application (sNDA) for use as a …

… and Drug Administration (FDA) for the resubmission of the New Drug Application (NDA) of reproxalap … press release stated that “the NDA ‘failed to demonstrate efficacy in … the trial submitted to the NDA that may have affected interpretation …

… Drug Administration (FDA) for the resubmission of the New Drug Application (NDA) of reproxalap … , the FDA stated in the letter that the NDA ‘failed … trial submitted to the NDA that may have affected … the results, which the FDA stated may be related to …

… actively recruiting with an investigational new drug application for ZW251 planned for mid …