New drug application
![Galera Therapeutics, Avasopasem, Complete Response Letter, New drug application, Avasopasem Manganese, Rejected by FDA](https://pharmtales.com/wp-content/uploads/2023/08/FDA-Denies-Approval-for-Galeras-Oral-Mucositis-Drug.jpg)
FDA Denies Approval for Galera’s Oral Mucositis Drug
SG Tylor
The FDA has issued a complete response letter in response to the new drug application (NDA) for avasopasem manganese (GC4419), ...
![Cyclophosphamide Injection's NDA for a Number of Cancers Receives FDA Approval](https://pharmtales.com/wp-content/uploads/2023/07/Cyclophosphamide-Injections-NDA-for-a-Number-of-Cancers-Receives-FDA-Approval.jpg)
FDA Approves Cyclophosphamide Injection NDA for Multiple Cancers
SG Tylor
Source – Nevakar Injectables On July 3, 2023 the FDA has approved a new drug application (NDA) for 200-mg/mL vials ...
![Verona Pharma has recently filed a New Drug Application to FDA for the use of ensifentrine as a maintenance treatment for chronic obstructive pulmonary disease](https://pharmtales.com/wp-content/uploads/2023/06/Verona-Pharma-has-recently-filed-a-New-Drug-Application-to-FDA-for-the-use-of-ensifentrine-as-a-maintenance-treatment-for-chronic-obstructive-pulmonary-disease-Cat_-latest-News-Pharma.jpg)
Verona Pharma has recently filed a New Drug Application to FDA for the use of ensifentrine as a maintenance treatment for chronic obstructive pulmonary disease
SG Tylor
Source – Verona Pharma On June 27, 2023, Verona Pharma announced the submission of a New Drug Application (NDA) to ...
![FDA Prolongates PDUFA Nirogacestat's NDA for desmoid tumors is three months from today](https://pharmtales.com/wp-content/uploads/2023/06/FDA-Prolongates-PDUFA-Nirogacestats-NDA-for-desmoid-tumors-is-three-months-from-today.jpg)
FDA Prolongates PDUFA Nirogacestat’s NDA for desmoid tumors is three months
SG Tylor
Source – SpringWorks According to SpringWorks Therapeutics on June 7, 2023, the FDA has extended the Prescription Drug User Fee ...